Content uploaded by Joseph B Stanford
Author content
All content in this area was uploaded by Joseph B Stanford on Oct 24, 2014
Content may be subject to copyright.
Creighton-Model NaProEducation Technology for avoiding pregnancy
Abstract
To evaluate the use effectiveness of Creighton Model (CrM) NaProEducation Technology for avoiding pregnancy.
CrM is a medical model of natural procreation education that is a fully standardized modification of the Billings ovulation method. This system has been used as a means to avoid pregnancy and has been prospectively evaluated in five use effectiveness studies. A prospective life-table analysis of the five studies (meta-analysis) was undertaken, yielding both net and gross rates. Discontinuation rates were also calculated. These studies were conducted at CrM centers in Omaha, St. Louis, Wichita, Houston, and Milwaukee.
A total of 1,876 couples used CrM NET for a total of 17,130.0 couple months of use. The method and use effectiveness rates for avoiding pregnancy were 99.5 and 96.8 at the 12th ordinal month and 99.5 and 96.4 at the 18th ordinal month, respectively. The discontinuation rate was 11.3% at the 12th ordinal month and 12.1% at the 18th ordinal month.
CrM is highly effective as a means of avoiding pregnancy in both its method and use effectiveness. The method effectiveness has remained stable over the years of the studies, but the use effectiveness for avoiding pregnancy appears to have improved over the study period.
... Various mucus-only FAMs have demonstrated high perfect-use contraception rates: Billings Ovulation Method ® : 96.6%-98.9% (Bhargava et al. 1996, Trussell andGrummer-Strawn 1991), Creighton Model System (CrMS) of FertilityCare 99.5% effective (Hilgers and Stanford 1998). ...
... Although RCTs would improve the evidence base (Grimes et al. 2004), they may be problematic in this arena given pragmatic and ethical issues including recruitment methods, FAM instruction, and pregnancy intention of the couple. Effectiveness of the various FAMs for avoiding pregnancy has been reviewed for individual methods (Fehring, Schneider, and Barron 2008, Hilgers and Stanford 1998, The European Natural Family Planning Study Groups 1999 as well as in comparison with one another (Manhart et al. 2013, Peragallo Urrutia et al. 2018, Grimes et al. 2004). ...
Alzheimer`s disease (AD) is the most common and incurable form of dementia. The present AD treatments produce only an uncertain amelioration of symptoms. Research on AD has particularly focused on the central nervous system. Though, some systemic and peripheral abnormalities are now clearly understood that are associated to AD. Current research on these alterations that leads to AD are becoming further defined more evidently. Two microscopic features contribute for the depiction of the disease, the amyloid plaques and neurofibrillary tangles. All these aspects are accountable for the deliberate and gradual weakening of memory that disturb the cognitive control, language, thinking and personality. For the diagnosis of AD, some neuropsychological tests are being performed in various spheres of cognitive functions. To date, cholinesterase inhibitors are used as a drug for the treatment of AD, because these are the individual drugs that have depicted substantial enhancements in the cognitive functions of AD patients. Despite the efficacy of cholinesterase inhibitors, the degeneration of neurons is continuing even while being treated an AD patient. For this cause, further biochemical pathways related to pathophysiology of AD have been revealed as an alternative for the treatment of these conditions such as hindrance of glycogen synthase kinase-3β and β-secretase. The present chapter aims to conduct a review of the pathophysiology, symptoms, epidemiology, analysis and treatment of AD.
... [16][17][18] Woman's observations of their own cervical mucus (cervical fluid) constitute another biomarker for ovulation, which has minimal cost, can be used many settings, and has been used to develop and validate protocols for identifying ovulation. 11,[19][20][21][22] Based on cervical mucus observations, the estimated day of ovulation, or "Peak Day", is defined as the "last day" when women observe cervical mucus present which is clear, stretchy, or has a slippery or lubricative sensation at the vulva, with some slight variations of definition for different investigators. 19,23 Studies in many different settings have confirmed that the cervical mucus Peak Day identified by women falls within plus or minus 3 days of ovulation in at least 95% of cycles, as determined by serum or urine LH, serum progesterone, or ultrasound. ...
... For each cycle, we calculated the number (%) classified correctly for the Peak Day determined by each of the approaches with referent day (1 day after urine LH surge) as follows: exactly the same day, within ±1 day, 2 days, 3 days, and 4 days. We assessed agreement between the four approaches and the reference day (1 day after urine LH surge) via the Pearson correlation coefficient (within ± 4 days and for all days within the cycle) as well as the weighted Kappa coefficient (95% confidence interval [CI]) for exact agreement (day ≤12, 13,14,15,16,17,18,19,20,21,22, ≥23), using Fleiss-Cohen weights. Finally, in order to better understand demographic, reproductive, and life style factors related to agreement (within ±1 day and exact), we calculated unadjusted and adjusted prevalence ratio (PR) and 95% CIs using modified Poisson regression with robust error variance taking into account multiple cycles per woman. ...
Background:
Previous research has demonstrated that women instructed in fertility awareness methods can identify the Peak Day of cervical mucus discharge for each menstrual cycle, and the Peak Day has high agreement with other indicators of the day of ovulation. However, previous studies enrolled experienced users of fertility awareness methods or were not fully blinded.
Objective:
To assess the agreement between cervical mucus Peak Day identified by fertile women without prior experience on assessing cervical mucus discharge with the estimated day of ovulation (1 day after urine luteinising hormone surge).
Methods:
This study is a secondary analysis of data from a randomised trial of the Creighton Model FertilityCareTM System (CrM), conducted 2003-2006, for women trying to conceive. Women who had no prior experience tracking cervical mucus recorded vulvar observations daily using a standardised assessment of mucus characteristics for up to seven menstrual cycles. Four approaches were used to identify the Peak Day. The referent day was defined as one day after the first identified day of luteinising hormone (LH) surge in the urine, assessed blindly. The percentage of agreement between the Peak Day and the referent day of ovulation was calculated.
Results:
Fifty-seven women with 187 complete cycles were included. A Peak Day was identified in 117 (63%) cycles by women, 185 (99%) cycles by experts, and 187 (100%) by computer algorithm. The woman-picked Peak Day was the same as the referent day in 25% of 117 cycles, within ±1 day in 58% of cycles, ±2 days in 84%, ±3 days in 87%, and ±4 days in 92%. The ±1 day and ± 4 days' agreement was 50% and 90% for the expert-picked and 47% and 87% for the computer-picked Peak Day, respectively.
Conclusions:
Women's daily tracking of cervical mucus is a low-cost alternative for identifying the estimated day of ovulation.
... com. In this case she began recording her cycle with the Creighton model FertilityCare System [9,10]. See the data summary and Fig. 2 ...
Background
Restorative reproductive medicine represents a comprehensive approach to subfertility (infertility and miscarriage) with investigations, diagnoses, and treatments combined with fertility charting to restore optimal reproductive function. Restorative reproductive medicine assumes that multiple factors need to be identified and treated (cycle optimization) for up to 12 cycles to achieve a successful pregnancy. Conception can occur during normal intercourse without intrauterine insemination or in vitro fertilization.
Case presentation
A 35-year-old Croatian female presented for fertility treatment in May 2019 with a previous diagnosis of polycystic ovaries, infertility of 16 years duration, and 8 unsuccessful embryo transfers with in vitro fertilization and intracytoplasmic sperm injection. She was gravida 3 para 0, with 2 miscarriages after spontaneous conception at 5–6 weeks gestation in 2002 and 2004, followed by a miscarriage after in vitro fertilization at 12 weeks gestation in 2011. We initially found poor follicle function and suboptimal progesterone levels. Restorative reproductive medicine treatment resulted in conception after two cycles of treatment. This pregnancy ended in miscarriage at 7 weeks 4 days. Additional investigations found a balanced Robertsonian translocation (13, 14) and a uterine septum. We achieved repeat fertilization with restorative reproductive medicine after three cycles of treatment following resection of the uterine septum and ovulation induction with letrozole and human chorionic gonadotrophin. She had a full-term healthy pregnancy and live birth in 2021.
Conclusion
We propose that a full evaluation of underlying factors, and up to 12 cycles of cycle optimization, should be offered to subfertile patients before considering in vitro fertilization treatment.
... Serum levels of the reproductive hormones, LH, estradiol, and P have been used for decades to study fertility and treat infertility [21,22]. With the development of urinary LH, and later, urinary estrone-3-glucuronide home kits, hormonal diagnostic adjuncts became available to incorporate more traditional NFP methods [23][24][25][26][27][28][29][30]. Such advances in what is now called Fertility Assessment-Based Methods(FAMs) more recently include test strips for urinary PDG, which are based upon a threshold signal of 5-7 µg/mL (15.6-21.8 ...
Background and Objectives: The Fertility Indicator Equation (FIE) has been shown to signal the fertile phase during the ovulatory menstrual cycle. It was hypothesized that this formulation, a product of two sequential normalized changes with a sign indicating direction of change, could be used to identify the transition from ovulatory to luteal phase with daily serum progesterone (P) and urinary pregnanediol-3-glucuronide (PDG) levels. Materials and Methods: Day-specific serum P levels from two different laboratories and day-specific urinary PDG levels from an additional two different laboratories were submitted for FIE analysis. These day-specific levels included mean or median, 5th, 10th, 90th and 95th percentile data. They were indexed to the day of ovulation, day 0, by ultrasonography, serum or urinary luteinizing hormone (LH). Results: All data sets showed a clear “cluster”—a periovulatory sequence of positive FIE values with a maximum. All clusters of +FIE signaled the transition from the ovulatory to luteal phase and were at least four days in length. The start day for the serum P and urinary PDG FIE clusters ranged from −3 to −1 and −3 to +2, respectively. The end day for serum P and PDG clusters went from +2 to +7 and +4 to +8, respectively. Outside these periovulatory FIE-P and FIE-PDG clusters, there were no consecutive positive FIE values. In addition, the maximum FIE-P and FIE-PDG values throughout the entire cycles were found in the clusters. Conclusions: FIE analysis with either daily serum P or urinary PDG levels provided a distinctive signature to recognize the periovulatory interval. The Fertility Indicator Equation served to robustly signal the transition from the ovulatory phase to the luteal phase. This may have applications in natural family planning especially with the recent emergence of home PDG tests.
... The majority of fertility awareness/natural family planning (NFP) methods encompass subjective observations of cervical mucus/cervical-vaginal fluid (CVF) [1][2][3]. The physical properties of cervical mucus/CVF that lend themselves to female self-observation can be even more accurate in assessing the fertile time than timing relative to the point of ovulation [4]. ...
: To evaluate the cervical-vaginal mucin, CA125, as a measure of fertility and possible method for natural family planning (NFP). Cervical-vaginal fluid (CVF) swab samples have been previously used to measure CA125, ‘Qvaginal CA125 levels’, as a function of time of cycle relative to Day 0, the first day of positive urine LH (luteinizing hormone). Data from 15 women, 20 cycles were used with an algorithm to establish the Fertile Start Day (FSD) for the cycles. The FSD was determined as either the second consecutive day of ≥20% Qvaginal CA125 rise or the first day of ≥400% rise. The interval, (FSD to Day +3), was used as the theoretical window of fertility, and conception rates assuming abstinence during this predicted period of fertility were computed using published day-specific probabilities of conception (PoC). The mean FSD was Day −4.8 ± 0.5 (SE), 95% CI (−5.9, −3.7). The estimated pregnancy failure rate (PFR) with abstinence during [FSD, +3] was 10.7% ± 2.0% (SE), 95% CI (6.9%, 14.8%); with exclusion of one cycle with very low levels of Qvaginal CA125, the estimated PFR was 9.8% ± 1.9%, 95% CI (6.3%, 13.8%). Furthermore, the day-specific Qvaginal CA125 values were normalized to the respective peak Qvaginal CA125 for each cycle, and a mean normalized day-specific Qvaginal CA125 plot was generated. The first derivative of the mean normalized day-specific Qvaginal CA125 plot showed a significant increase between Day -4.5 and Day -3.5, which correlated with the mean FSD. A Qvaginal CA125-based method holds promise as a means to identify the start of the fertile window and may prove useful in NFP, especially when combined with available home hormonal fertility awareness kits.
Objectives
To summarize the evidence on typical and perfect-use effectiveness of fertility awareness-based methods for avoiding pregnancy during the postpartum period, whether breastfeeding or not.
Study design
We conducted a systematic review of studies published in English, Spanish, French, or German by November 2021 in MEDLINE, EMBASE, CINAHL, Web of Science, and ClinicalTrials.gov. Abstract and full text reviews were completed by 2 independent reviewers. Study inclusion: at least 50 subjects who enrolled prior to experiencing 3 cycles after childbirth and were using a specific fertility awareness-based method to avoid pregnancy; unintended pregnancy rate or probability calculated; postpartum amenorrheic and postpartum cycling individuals analyzed separately; and prospectively measured pregnancy intentions and outcomes. Outcomes were abstracted and study quality was systematically assessed by 2 independent investigators.
Results
Four studies provided effectiveness data for 1 specific fertility awareness-based method among postpartum individuals. Of these, there were zero high quality, 1 moderate quality, and 3 low quality for our question of interest. Typical-use pregnancy probability for the first 6 cycles postpartum for Marquette Method users was 12.0 per 100 women years (standard error [SE] not reported) and for Billings Ovulation Method users ranged from 9.1 (SE 3.9) for non-lactating women <30 years old to 26.8 (SE 4.6) for lactating women <30 years old. Typical-use pregnancy probabilities for the first 6 months post-first menses for the Postpartum Bridge to Standard Days Method users was 11.8 (95% confidence interval 6.01-17.16) and for Billings Ovulation Method users was 8.5 per 100 women (SE 1.7).
Conclusion
The current evidence on the effectiveness of each fertility awareness-based method for postpartum persons is very limited and of mostly low quality. More high quality studies on the effectiveness of fertility awareness-based method in postpartum persons are needed to inform clinical counseling and patient-centered decision-making.
Implications
Although postpartum individuals may desire to use fertility awareness-based methods to avoid pregnancy, the evidence of the effectiveness of fertility awareness-based methods in this population is limited. More high-quality studies are needed to inform shared decision-making.
Aim:
Simplified contraceptive method-efficacy and/or typical-use effectiveness rates are commonly used for direct comparison of the various contraceptive methods. Use of such effectiveness rates in this manner is, however, problematic in relation to the fertility awareness methods (FAMs). The aim of this review is to critically examine current international representation of contraceptive effectiveness for the various FAMs in clinical use. This review also details important issues when appraising and interpreting studies on FAMs used for avoiding pregnancy.
Methods:
Current international literature regarding contraceptive effectiveness of FAMs was surveyed and appraised. This included World Health Organization and Centers for Disease Control (USA) resources, key clinical studies and recent systematic reviews. Chinese literature was also searched, since these data have not been reported in the English literature.
Results:
Reliance on certain historical studies has led to the misrepresentation of contraceptive effectiveness of FAMs by perpetuation of inaccurate figures in clinical guidelines, the international literature and the public domain. Interpretation of published study results for FAMs is difficult due to variability in study methodology and other clinical trial quality issues. Recent systematic analyses have noted the considerable issues with study designs and limitations. Several non-English published studies using the Billings Ovulation Method have demonstrated that a broader review of the literature is required to better capture the data potentially available.
Conclusion:
A deeper understanding by clinicians and the public of the applicability of contraceptive effectiveness rates of the various FAMs is needed, instead of reliance on the inaccurate conglomerate figures that are widely presented.
The Sacred Congregation for the Doctrine of the Faith has declared the moral liceity of hysterectomy when certain medical criteria are met but does not exclude other options, "for example, recourse to infertile periods or total abstinence." Consequently, there may be couples who prefer to use natural family planning (NFP) methods. We shall refer to these in this article. The efficacy of NFP methods is determined by knowing the day of ovulation. To that end, three parameters are used: the presence and consistency of cervical mucus, measurement of the basal body temperature, and the determination of particular hormones in urine. Of the NFP methods used, the so-called sympto-thermal method seems to be the most effective. It has been concluded that the postovulatory or luteal phase of the female menstrual cycle is the safest time to avoid pregnancy if the couple has sexual intercourse during this period. Nevertheless, the use of NFP methods has limitations if the length of the cycles varies, there are fluctuations in the basal temperature, or when there are vaginal infections. Urinary hormone levels can also be altered by the use of antibiotics or psychotropic drugs. In general, however, it can be concluded that NFP methods, if used in the conditions mentioned herein, offer a high degree of reliability, similar to that of artificial contraceptive methods. Accordingly, if pregnancy must be avoided in the medical circumstances to which the Congregation for the Doctrine of the Faith refers, NFP methods can effectively replace hysterectomy, thereby circumventing the medical difficulties of this practice.
Summary:
The Sacred Congregation for the Doctrine of the Faith has declared the moral liceity of hysterectomy when certain medical criteria are met but does not exclude other options, "for example, recourse to infertile periods or total abstinence." Consequently, there may be couples who prefer to use natural family planning (NFP) methods. We shall refer to these in this article. In general, it can be concluded that NFP methods, if used in the conditions mentioned herein, offer a high degree of reliability, similar to that of artificial contraceptive methods. Accordingly, if pregnancy must be avoided in the medical circumstances to which the Congregation for the Doctrine of the Faith refers, NFP methods can effectively replace hysterectomy, thereby circumventing the medical difficulties of this practice.
The Billings/ovulation method is a periodic abstinence method of regulating births based on the client's interpretation of changing patterns in secretions of cervical mucus monitored by external self-examination. It was developed in Australia and is now widely promoted overseas. This paper outlines the method's recent history and goes on to discuss its physiological basis, its use-effectiveness as measured in a number of major trials, and some evidence concerning its general acceptability and applicability in family planning programs.
Objective: To determine the use effectiveness of the Creighton model ovulation method in avoiding and achieving pregnancy.
Design: Prospective, descriptive.
Setting: A natural family planning clinic at a university nursing center.
Participants: Records and charts from 242 couples who were taught the Creighton model. The sample represented 1,793 months of use of the model.
Main outcome measure: Creighton model demographic forms and logbook.
Results: At 12 months of use, the Creighton model was 98.8% method effective and 98.0% use effective in avoiding pregnancy. It was 24.4% use effective in achieving pregnancy. The continuation rate for the sample at 12 months of use was 78.0%.
Conclusion: The Creighton model is an effective method of family planning when used to avoid or achieve pregnancy. However, its effectiveness depends on its being taught by qualified teachers. The effectiveness rate of the Creighton model is based on the assumption that if couples knowingly use the female partner's days of fertility for genital intercourse, they are using the method to achieve pregnancy.
Channel formation in dried cervical mucus and the presence or absence of fern formation are correlated. The mean number of channels was 9.2 when the fern was negative, 42.8 when the fern was poor positive, and 73.9 when the fern was good positive. The difference between the means in the 3 groups was statistically significant. The channel number in dried cervical mucus and the presence or absence of fern formation are correlated with the day of the menstrual cycle in which the specimens were obtained and with the woman's observation of the PEAK mucus symptom while using the ovulation method of natural family planning. The data organized itself more clearly when it was related to the woman's observation of the PEAK symptom. This has been explained by the fact that the PEAK mucus symptom is essentially an ovulatory event. The reliability of the woman's vulvar observations while using the ovulation method was tested against observations of cervical mucus obtained from the level of the endocervix. In those vulvar observations that are considered fertile by the method, the channel number and the frequency of good positive ferning were higher than in those observations that are considered infertile. When the vulvar observations that indicate fertility were compared with those vulvar observations that indicate infertility, the difference was statistically significant. Finally, a practical model of human fertility is described using practical experience with the ovulation method, the woman's vulvar observations while using the method, and the channel and fern formation of endocervical mucus. A progressively declining index of fertility is described that is statistically significant.
Analysis of data from the 1988 National Survey of Family Growth--corrected for the underreporting of abortion--reveals that contraceptive failure during the first year of use remains a serious problem in the United States, contributing substantially to unintended pregnancy. The pill continues to be the most effective reversible method for which data were available (8% of users accidentally became pregnant during the first year of use), followed by the condom (15%). Periodic abstinence is the method most likely to fail (26%), but accidental pregnancy is also relatively common among women using spermicides (25%). Failure rates vary more by user characteristics such as age, marital status and poverty status than by method, suggesting the extent to which failure results from improper and irregular use rather than from the inherent limitations of the method.
Throughout Germany, 851 women who were instructed in natural family planning participated in a prospective study. Of these, 255 women with 3174 cycles used only natural family planning for family planning and 274 women with 3995 cycles occasionally used barrier methods in the fertile phase. For natural family planning--only users, the Pearl rate for unplanned pregnancy was 2.3 and for mixed-method users 2.1. Most pregnancies resulted from unprotected intercourse during the fertile phase, and the use of barrier methods does not reduce risk-taking.
This report provides an update of the authors' previous estimates of first-year probabilities of contraceptive failure for all methods of contraception. Estimates are provided of failure during typical use (which includes both incorrect and inconsistent use) and during perfect use (correct use at every act of intercourse). The difference between these two probabilities provides a measure of how forgiving of imperfect use each method is. These revisions are prompted by recent studies that provide the first estimates of failure during perfect use for periodic abstinence and the cervical cap, by more complete evaluations of implants, and by the appearance of the Copper T 380A and disappearance of other IUDs from the US market. Also provided is a more complete explanation of how the previous estimate of the probability of becoming pregnant while relying solely on chance should be interpreted, and this estimate is revised slightly downward.
A methodology for the statistical evaluation of the effectiveness and acceptability of 2 groups of contraceptive methods utilizing life-table procedures adapted for this purpose is described. 2 sets of illustrative tables one for clinical data on IUDs and the other for clinical data on oral medication which is also applicable to other methods of contraception that can be discontinued by the user at any time are presented. The procedures for the statistical analysis of use-effectiveness of which the 2 most important components are the antifertility effect expressed as the rate of accidental pregnancy and acceptability as reflected in the rate of continued use are described. To measure use-effectiveness by life-table procedures certain infomrati on is required: 1) the period covered by the study; 2) the number of women who accept the method (for IUDs the number of first insertions) by date of acceptance; and 3) for each termination the date of acceptance and the reason for discontinuing the contraceptive method by duration of use (ordinal months of use). Numerous self-checking features are included in the analysis.
The final results of a prospective comparative study of two methods of natural family planning indicate a significant difference in the 12 month net cumulative pregnancy rates between the ovulation and symptothermal methods. These differences are on the order of two to one in favor of the symptothermal method. Pearl pregnancy rates confirm similar differentials between the two methods. Dropout rates for both methods were high. Lack of interest or dissatisfaction with the method was the major reason for dropout training while pregnancy or desire for pregnancy were the major reasons for dropout during the formal phase of the study.
Results of a comparative study of the ovulation method (OM) and symptothermal method (STM) of natural family planning in Colombia are presented. Recruitment of volunteer couples began in August, 1976, and continued through December, 1978, during which time 566 couples were randomly assigned to one or the other of the two methods. The study included 3 to 5 months of training in the method assigned, after which the couples entered the follow-up phase of the study. They remained in follow-up until (1) they dropped out or (2) the study closed in June, 1979. Total dropout rates were high for both methods of natural family planning. One year after entry into the follow-up phase of the study, net pregnancy rates were 24.2% for OM users and 19.8% for STM users. Gross pregnancy rates were 29.2% for OM and 26.1% for STM. Differences in pregnancy rates between the two methods were not statistically significant.