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Natural family planning with and without barrier method use in the fertile phase: Efficacy in relation to sexual behavior: A German prospective long-term study
Abstract
A large prospective long-term study with users of natural family planning (NFP) methods has been conducted to analyze the relation between unintended pregnancy rates and sexual behavior with special reference to barrier method use in the fertile phase. Seven hundred and fifty eight NFP beginners, 19-45 years of age, 14 870 cycles, 28 unintended pregnancies were studied.
Of the couples, 54.2% use NFP only or predominantly and 45.9% use mixed methods (additional barrier method use in the fertile phase in 55.7% of the cycles). The overall pregnancy rate after 12 cycles of exposure is 2.2% according to the actuarial method. There is no significant difference between NFP users and mixed methods users and also no significant effect of duration of use in the first 5 years of exposure. During "perfect use" the pregnancy rate at 12 months is 0.63%. When only protected intercourse takes place in the fertile phase the pregnancy rate is 0.45%. The symptothermal method of NFP is most unforgiving for imperfect use (unprotected intercourse in the fertile phase). However, it is extremely effective when either abstinence or protected intercourse is used in the fertile phase.
Aim This official guideline was published and coordinated by the DGGG, OEGGG and SGGG with the involvement of other medical societies. The aim was to provide a consensus-based overview of non-hormonal forms of contraception based on an evaluation of the relevant literature. The first part of these summarized statements and recommendations presents natural family planning methods such as lactational amenorrhea, barrier methods and coitus interruptus. The second part will focus on intrauterine devices and sterilization methods.
Methods This S2k-guideline was developed by representative members from different medical professions on behalf of the guidelines commission of the DGGG, OEGGG and SGGG using a structured consensus process.
Recommendations The guideline provides recommendations on the indications for, safety of use, benefits, and limitations of the different methods as well as recommendations on providing advice and other aspects of non-hormonal contraception. Natural family planning methods, lactational amenorrhea, barrier methods and coitus interruptus are discussed.
Aim This official guideline was published and coordinated by the DGGG, OEGGG and SGGG with the involvement of other medical societies. The aim was to provide a consensus-based overview of non-hormonal forms of contraception based on an evaluation of the relevant literature. The first part of these summarized statements and recommendations presents natural family planning methods such as lactational amenorrhea, barrier methods and coitus interruptus. The second part focuses on intrauterine devices and sterilization.
Methods This S2k-guideline was developed by representative members from different medical professions on behalf of the guidelines commission of the DGGG, OEGGG and SGGG using a structured consensus process.
Recommendations The guideline provides recommendations on the indications for, safety of use, benefits, and limitations of the different methods as well as recommendations on providing advice and other aspects of non-hormonal contraception. This summary presents recommendations and statements about intrauterine devices and female and male sterilization.
Natural family planning (NFP), also known as fertility awareness-based methods (FABM), includes methods of cycle monitoring that can be used to plan or avoid pregnancy. There are numerous methods of NFP that show substantial differences in safety, practicability and acceptance by the user.
To present aspects in the context of the development of S2K guidelines for non-hormonal contraception that are crucial for assessing the practical usability of an NFP method and should therefore form the basis for counselling.
The evaluation and detailed presentation of the NFP methods listed in the guidelines include those that have sufficient breadth and acceptance of application in Europe. Published controlled studies, particularly on contraceptive effectiveness are prerequisites.
Ultimately included in the guidelines are one single-index method and three double-index methods. For each of the NFP methods included, statements can be made about the probability of conception within the fertile phase, on the contraceptive efficacy and acceptability. The basic requirement for an NFP method to be recommended is that users observe and evaluate cyclic changes of physiological symptoms during the current cycle. This means the users are no longer dependent on a regular cycle. Methods not included in the guidelines for this reason are the old calendar-based methods. The methods using temperature alone are also not included, which are now largely obsolete as well as NFP methods that are mainly used in non-European countries. The main conclusion of the guidelines concerning NFP with high contraceptive safety is that only evidence-based symptothermal methods with high effectiveness should currently be recommended in European countries.
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.
In 2019, the Congregation for the Doctrine of the Faith (CDF) issued a statement that a woman could morally undergo a hysterectomy to avoid serial miscarriages if her uterus were incapable of sustaining a child until viability because the procedure would not constitute a direct sterilization. We believe the CDF’s conclusion and line of argumentation are both mistaken. Since the proposed hysterectomy seeks to make impossible what is presently possible—conceiving a child—it must therefore constitute a direct sterilization, which the Church has long taught is immoral. Using the Principle of Totality, we offer and defend a more straightforward interpretation of the case, arguing that while the woman’s condition is both tragic and chronic, spiritual counseling and training in natural family planning should be recommended, as a hysterectomy is not medically indicated in this case.
Summary
The Congregation for the Doctrine of the Faith (CDF)'s recently issued a statement claiming that a woman could morally undergo a hysterectomy to avoid serial miscarriages if her uterus were incapable of sustaining a child until viability on the grounds that the procedure would not constitute a direct sterilization. We argue this is mistaken, and that the procedure would constitute a direct sterilization.
Natural family planning (NFP) is a type of family planning that is based on fertility awareness and its application in achieving the couple's goal of either having or preventing pregnancy. Any of the natural methods either independently or combined is a great alternative to other forms of alternative contraception. The general objective of this scoping review was to identify research gaps and clarify key concepts in existing literature with regards to NFP and to examine the extent, range, and nature of research activity about NFP. The scop-ing review was underpinned by the five-stage framework Arksey and O'Malley and one hundred ninety nine articles were included in the study. The results indicate that use of natural family planning involves an interplay of factors that influence either the user or the provider. Common goals for use are achieving or preventing preventing pregnancy. No adverse pregnancy outcomes were found. There is an increasing and evolving trend of research activity across all natural family planning methods.
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.
Natürliche Familienplanung (NFP) ist ein Sammelbegriff für zahlreiche Methoden, die sich hinsichtlich Sicherheit, Praktikabilität und Akzeptanz erheblich unterscheiden. Die alten Kalendermethoden sind zumindest im europäischen Kontext obsolet. Bei heutigen NFP-Methoden beobachten die Anwenderinnen Veränderungen von Körpersymptomen im aktuellen Zyklus, sie sind daher nicht mehr auf einen regelmäßigen Zyklus angewiesen. Unter den verschiedenen NFP-Methoden wird aktuell die Sensiplan-Methode empfohlen, da sie wissenschaftlich überprüft ist und in die Kategorie der sehr sicheren Familienplanungsmethoden eingeordnet werden kann (Methodensicherheit 0,4 Schwangerschaften/100 Frauenjahre). Es ist jedoch kritisch anzumerken, dass die Anwenderabhängigkeit bei natürlichen Methoden höher ist als bei den meisten anderen Familienplanungsmethoden. Deshalb sind natürliche Methoden nur für Personen geeignet, die motiviert sind, sich an die Regeln zu halten. Die sehr guten Ergebnisse mit der Sensiplan-Methode wurden nach Beratung durch ausgebildete NFP-Berater/innen erreicht. Einige andere NFP-Methoden, auch Zykluscomputer, weisen eine mittlere Sicherheit auf, häufig fehlen jedoch entsprechende Studien.
Fertility awareness-based methods (FABMs) of family planning involve monitoring various signs and symptoms of fertility during the menstrual cycle to identify the “fertile window,” or the days of the cycle when unprotected intercourse is most likely to result in pregnancy. Signs and symptoms include menstrual cycle length, basal body temperature, urinary hormone measurements, and/or cervical fluid and may be used alone or in combination. Fertility signs reflect both physiological changes during the menstrual cycle and the life cycle of the ovum and sperm. Women learn to observe or measure and interpret these signs according to the instructions of their chosen FABM and avoid unprotected intercourse on fertile days. FABMs are appropriate for those who choose to use them, are able and willing to observe one or more fertility signs, and are in relationships that support the use of a coitus-related method such as a condom or abstaining from intercourse on fertile days.
Das Familienplanungsverhalten hat sich in den letzten Jahrzehnten wesentlich verändert. Schwangerschaften werden oft nach langjähriger Kontrazeption erst für das letzte Viertel der fertilen Jahre einer Frau geplant, in der die Fruchtbarkeit möglicherweise bereits gravierend nachgelassen hat. Verantwortungsvolle Familienplanung bedeutet, bei der Kontrazeption von heute an die Reproduktion von morgen zu denken. Das erfordert, abhängig von den Lebensphasen das Risiko Konzeption und (später) die Konzeptionschancen gegeneinander abzuwägen. Damit ändert sich der Anspruch an kontrazeptive Methoden im Laufe des Lebens.
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.
Previously published estimates of probabilities of method and user failure for all contraceptive methods suffer from a serious methodological error and are biased downward, with the extent of bias unknown. Data from a World Health Organization clinical trial of the ovulation method of periodic abstinence were used to provide the first correctly calculated measures of method and user efficacy and to determine the characteristics that distinguish women who consciously take risks from those who do not. Probabilities of pregnancy during the first year are 3.1 percent during perfect use (method failure) and 86.4 percent during imperfect use (user failure). Thus, if used perfectly, the ovulation method is very effective. However, it is extremely unforgiving of imperfect use. Because perfect compliance is difficult for many couples who desire intercourse when it is forbidden by ovulation method rules, and because the risk of pregnancy during imperfect use is so great, the ovulation method cannot be considered an ideal contraceptive method for the typical couple, who are likely to be less compliant than couples who volunteer for a clinical trial. The probability of an accidental pregnancy is greatest when any of the three most serious rules--no intercourse during mucus days, within three days after the day of peak fecundity or during times of stress--are broken. Those who have a poor attitude toward the rules are more likely to take risks, including serious risks. Those who get away with taking a risk (i.e., do not get pregnant) are very likely to take risks again. Because breaking the most serious rules entails a 28 percent risk of pregnancy per cycle, those likely to take risks should be counseled about the probable consequences.
This study describes 4 years of verification of effectiveness and applicability of BBT and symptothermal methods. The couples chosen had to undergo a 6-month-long study phase, and be psychologically motivated and well trained in NFP. During this period, particular emphasis was given to the motivational factor, which was expanded in its anthropological, relational, pedagogical and, sometimes, moral contents. Four hundred and sixty couples entered the program, for a total of 8,140 cycles, in which BBT, cervical mucus, and intercourse were charted. The Pearl Index for unplanted pregnancies was 3.6. Twenty-five unplanned pregnancies occurred in couples using NFP for spacing, and no pregnancies were reported in limiters.
Motivated and informed participants were recruited for a statistical evaluation of the effectiveness of the symptothermal method. Couples in five countries were selected on the following criteria: (1) the wife had to be between 19 and 44, (2) the wife had to be of proven fertility by having carried a fetus for at least 28 weeks, (3) the couple must have submitted one satisfactory temperature graph before being accepted, and (4) the couple must have expressed a willingness to submit temperature graphs for 24 months. Of the 1,022 couples selected, 826 completed the 2 years; only 35 were lost to follow up. Cycle length varied from 9 to 98 days, with an average of 28.43 days. Only 205 women had a variation of 8 days or less. A more complete analysis of the menstrual cycle data will be reported in another paper. The 1,022 couples contributed 21,736 cycles and reported 128 unplanned pregnancies, a rate of 7.47 conceptions per 100 woman years of exposure. Only 16 pregnancies occurred when the couples were following instructions, giving a theoretical effectiveness of .93 pregnancies per 100 woman years using the Pearl formula. Couples trying to prevent any pregnancies had a failure rate of 4.13%, those only delaying a pregnancy had a failure rate of 14.83%. The sympto-thermal method used alone had a failure rate of 7.16% while use of contraceptive devices with sympto-thermal method had a failure rate of 8.19%. The women in our sample averaged 13 cycles per year. Any valid comparative figure for NFP should be expressed in pregnancies per 1,300 cycles according to the modified Pearl index rather than 1,200 months. This gives a pregnancy rate of 7.66% as compared to 7.47% for 1,200 months.
A Natural Family Planning service was evaluated at the end of a 30-month developmental phase. There were 444 women taught and 322 method acceptor of which 248 intended to avoid pregnancy. NFP clients were older (mean age 26.9 vs 22.4 and 23.7 for comparison groups), and a larger percentage were married (83.1 per cent vs 23.0 per cent for the comparison group). After one year of use, the unplanned pregnancy rate was 14.4 per cent and the total dropout rate was 37.6 per cent by life table analysis.
For 10 years, a prospective study has been taking place in Germany to examine the use of natural family planning (NFP). As natural methods are behavioral methods, use-effectiveness, acceptability and continuation rates are very much influenced by patterns of sexual behavior. Therefore we performed an analysis of the sexual behavior of NFP users. Out of the data base of 1211 clients and 12,591 cycles we could identify a group of 300 women, all NFP beginners, with 5900 contraceptive cycles, who contributed at least 12 cycles with reliable recording of their sexual activity. Different groups were analyzed with methods of analysis of variance and regression models to find out significant differences in their sexual behavior with respect to sociodemographic structure and time of use. Nearly half of all the women systematically combine the fertility awareness part of NFP with other family planning methods. They use barriers in more than 60% of their cycles. The other half never or only in about 7% of their cycles use additional barrier methods. The latter show a clear decrease in barrier use in the course of time, whereas the frequent barrier users constantly combine the advantages of two family planning methods. Regarding the frequency of intercourse they are the sexually more active ones and show distinct sociodemographic characteristics. We could confirm the existence of three groups of NFP users, which differ significantly in their use of NFP as a family planning method. Despite these differences the low pregnancy rates indicate the conscious and risk-related sexual behavior of the group members.
The calendar method is perceived to be less effective than other methods of family planning. A large existing data set was used to determine how well the fertile time is identified using the traditional calendar method formula and to determine if better formulas could be developed to identify the fertile time more accurately and require less abstinence. We compared the traditional formula with three alternatives, two of which were developed for this analysis. All three alternative formulas performed better than the traditional formula in identifying the presumed fertile time. The result of our analysis is a summary table which can be used to select the best rules for testing the effectiveness of the calendar method.
Natu« rliche Familienplanung heute. Fu« r A ë rzte, Berater und interessierte Anwender
- Raith E P Frank
Raith E, Frank P, Freundl G. Natu« rliche Familienplanung heute. Fu« r A ë rzte, Berater und interessierte Anwender. Heidelberg, Berlin, New York: Springer, 1994.
The European Natural Family Planning Study Groups. Prospective European multi-center study of natural family planning (1989-1992): interim results
- G Freundl
- G. Freundl
Freundl G. The European Natural Family Planning Study Groups. Prospective European multi-center study of natural family planning (1989^1992): interim results. Adv Contracept. 1993;9:269^83.