Effects of the etonogestrel-releasing contraceptive implant inserted immediately postpartum on maternal hemostasis: A randomized controlled trial

Department of Obstetrics and Gynecology, Ribeirao Preto School of Medicine, University of São Paulo, Ribeirao Preto, SP, Brazil.
Thrombosis Research (Impact Factor: 2.45). 04/2012; 130(3):355-60. DOI: 10.1016/j.thromres.2012.03.029
Source: PubMed


The puerperium is the period of highest risk for thrombosis during a woman's reproductive life and it is an important time for initiating an effective contraceptive method in order to increase intergestational interval. Thus, the objective of the present study was to evaluated the effects of the etonogestrel (ENG)-releasing contraceptive implant inserted immediately postpartum on maternal hemostasis markers during the first six weeks of delivery.
Forty healthy women aged 18 to 35 years-old were randomized to receive either the ENG-releasing implant 24-48 h after delivery (implant group; n=20) or nothing (control group) until the sixth postpartum week. Blood samples were collected at 24-48 h and at 6 weeks after delivery, and hemostatic variables, including fibrinogen, coagulation factors, protein C, free protein S, antithrombin, α2-antiplasmin, plasminogen activator inhibitor 1, thrombin-antithrombin complex (TAT), prothrombin fragment (PF)1+2, and D-dimers, as well as normalized activated protein C sensitivity ratio (nAPCsr), thrombin time, activated partial thromboplastin time, and prothrombin time were evaluated.
Insertion of the ENG-releasing contraceptive implant did not change the physiological reduction in overall coagulation (TAT and PF1+2) and fibrinolysis (D-dimer) markers, or nAPCsr. Reductions in factors II, VII, X and fibrinogen and increases in factor V were greater in the control than in the implant group. Clotting factors remained within normal limits throughout the study.
The ENG-releasing contraceptive implant inserted immediately postpartum did not have negative effects on physiological variations of the hemostatic system during the first 6 weeks postpartum.

8 Reads
  • H Rott ·
    [Show abstract] [Hide abstract]
    ABSTRACT: Exogenous use of hormones leads to different impact on coagulation. Usually estrogen leads to an activation of coagulation, while use of progestogens alone do not. Combined oral contraceptives (COC) differs significantly regarding VTE risk depending on amount of estrogen and type of progestagen: COC containing desogestrol, gestoden or drospirenone in combination with ethinyl-estradiol (EE) (so called 3rd or 4th generation COC) are associated with a higher VTE risk than COC with EE and levonorgestrel or norethisterone (so called 2nd generation COC). The VTE risk for transdermal COC like vaginal ring (NuvaRing) or patch (Evra) is as high than than for COC of 3rd or 4th generation. 2nd generation COC should therefore be the first choice when prescribing hormonal contraception. Most PROGESTAGEN-only contraceptive methods do not increase VTE risk significantly. In patients with a history of venous thromboembolism (VTE) and /or a known thrombophilic defect COC are contraindicated, but progestagen-only contraceptives can be safely used in this patient group. New kinds of COC without EE but with Estradiolvalerat or Estradiol showed a much lower degree of coagulation activation than "classical" COC containing EE. If newer COC with Estradiolvalerat or Estradiol have a lower VTE risk, remains to be elucidated.
    Minerva medica 04/2013; 104(2):161-7. · 0.91 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: The single-rod, etonogestrel-releasing, subdermal implant (ENG implant) is the most effective, long-acting reversible method of contraception available. The failure rate of the ENG implant is 0.05%, which makes it more effective than female sterilization. It is discreet, easy to insert and remove, has no effect on future fertility and is associated with a number of noncontraceptive health benefits. The ENG implant is safe and effective when used in the postpartum and postabortion setting, and in women who have contraindications to estrogen. The most common reason cited for discontinuation is irregular and unpredictable bleeding. However, structured, preinsertion counseling can increase continuation and user satisfaction.
    Expert Review of Obstetrics &amp Gynecology 01/2014; 8(4). DOI:10.1586/17474108.2013.811941
  • [Show abstract] [Hide abstract]
    ABSTRACT: Postpartum contraception improves the health of mothers and children by lengthening birth intervals. For lactating women, contraception choices are limited by concerns about hormonal effects on milk quality and quantity and passage of hormones to the infant. Ideally, the contraceptive chosen should not interfere with lactation or infant growth. Timing of contraception initiation is also important. Immediately postpartum, most women have contact with a health professional, but many do not return for follow-up contraceptive counseling. However, immediate initiation of hormonal methods may disrupt the onset of milk production. To determine the effects of hormonal contraceptives on lactation and infant growth SEARCH METHODS: We searched for eligible trials until 2 March 2015. Sources included the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, POPLINE, Web of Science, LILACS,, and ICTRP. We also examined review articles and contacted investigators. We sought randomized controlled trials in any language that compared hormonal contraception versus another form of hormonal contraception, nonhormonal contraception, or placebo during lactation. Hormonal contraception includes combined or progestin-only oral contraceptives, injectable contraceptives, implants, and intrauterine devices.Trials had to have one of our primary outcomes: breast milk quantity or biochemical composition; lactation initiation, maintenance, or duration; infant growth; or timing of contraception initiation and effect on lactation. Secondary outcomes included contraceptive efficacy while breastfeeding and birth interval. For continuous variables, we calculated the mean difference (MD) with 95% confidence interval (CI). For dichotomous outcomes, we computed the Mantel-Haenszel odds ratio (OR) with 95% CI. Due to differing interventions and outcome measures, we did not aggregate the data in a meta-analysis. In 2014, we added seven trials for a new total of 11. Five reports were published before 1985 and six from 2005 to 2014. They included 1482 women. Four trials examined combined oral contraceptives (COCs), and three studied a levonorgestrel-releasing intrauterine system (LNG-IUS). We found two trials of progestin-only pills (POPs) and two of the etonogestrel-releasing implant. Older studies often lacked quantified results. Most trials did not report significant differences between the study arms in breastfeeding duration, breast milk composition, or infant growth. Exceptions were seen mainly in older studies with limited information.For breastfeeding duration, two of eight trials indicated a negative effect on lactation. A COC study reported a negative effect on lactation duration compared to placebo but did not quantify results. Another trial showed a lower percentage of the LNG-IUS group breastfeeding at 75 days versus the nonhormonal IUD group (reported P < 0.05) but no significant difference at one year.For breast milk volume, two older studies indicated lower volume for the COC group versus the placebo group. One trial did not quantify results. The other showed lower means (mL) for the COC group, e.g. at 16 weeks (MD -24.00, 95% CI -34.53 to -13.47) and at 24 weeks (MD -24.90, 95% CI -36.01 to -13.79). Another four trials did not report any significant difference between the study groups in milk volume or composition with two POPs, a COC, or the etonogestrel implant.Seven trials studied infant growth; one showed greater weight gain (grams) for the etonogestrel implant versus no method for six weeks (MD 426.00, 95% CI 58.94 to 793.06) but less compared with depot medroxyprogesterone acetate (DMPA) from 6 to 12 weeks (MD -271.00, 95% CI -355.10 to -186.90). The others studied POPs, COCs versus POPs, or an LNG-IUS. Results were not consistent across the 11 trials. The evidence was limited for any particular hormonal method. The quality of evidence was moderate overall and low for three of four placebo-controlled trials of COCs or POPs. The sensitivity analysis included six trials with moderate quality evidence and sufficient outcome data. Five trials indicated no significant difference between groups in breastfeeding duration (etonogestrel implant insertion times, COC versus POP, and LNG-IUS). For breast milk volume or composition, a COC study showed a negative effect, while an implant trial showed no significant difference. Of four trials that assessed infant growth, three indicated no significant difference between groups. One showed greater weight gain in the etonogestrel implant group versus no method but less versus DMPA.
    Cochrane database of systematic reviews (Online) 03/2015; 3(3):CD003988. DOI:10.1002/14651858.CD003988.pub2 · 6.03 Impact Factor
Show more