Effectiveness of a theory-based postpartum sexual health education program on women's contraceptive use: a randomized controlled trial

Background

The aim of this study was to evaluate the effectiveness of a refined theory-based Interactive Postpartum Sexual Health Education Program to enhance postpartum women's effective contraceptive behavior.

Study Design

Participants (N=250) were randomized to three groups. Experimental Group A received our intervention program via strategies that matched participants' learning preparedness, as determined by the transtheoretical model. Experimental Group B received only a pamphlet. The control group received routine education. Only Group A received health education. Data were collected at baseline, 3 days, 2 months and 3 months postpartum.

Results

Women who received theory-based postpartum sexual health education program had significantly greater contraceptive self-efficacy and were more likely to choose more effective contraceptive methods at 2 months postpartum than women in the routine teaching and interactive pamphlet-only groups.

Conclusion

Our theory-based Interactive Postpartum Sexual Health Education Program enhanced postpartum women's contraceptive self-efficacy and effective contraceptive behavior.     

The effect of immediate postpartum compared to delayed postpartum and interval etonogestrel contraceptive implant insertion on removal rates for bleeding

Objective

To determine whether the discontinuation rate of the etonogestrel contraceptive implant due to irregular vaginal bleeding among women with immediate postpartum insertion is increased compared to delayed postpartum and interval placement.

Study Design

This retrospective cohort study compared women who underwent immediate postpartum etonogestrel contraceptive implant insertion (within 96h of delivery) to delayed postpartum (6 to 12weeks postpartum) and interval insertion between January 2008 and December 2010. Charts were reviewed for date and reason for removal. A chi-squared test was used to compare discontinuation due to bleeding between cohorts. Baseline characteristics predictive of implant removal were evaluated by simple logistic regression.

Results

There were 259 women in the immediate postpartum group, 49 in the delayed postpartum group and 106 in the interval group. Average age at insertion was 22.6 (±5.5) years. Overall, 19.3% of women in the immediate postpartum group requested removal due to irregular bleeding compared to 18.4% in the delayed postpartum group [odds ratio (OR) 1.06, 95% confidence interval (CI) 0.48–2.33] and 20.8% in the interval group (OR 0.91, 95% CI 0.52–1.60). There was no difference between groups in premature removal rates for any side effect. There were no sociodemographic or clinical characteristics predictive of removal in any group.

Conclusion

One-fifth of etonogestrel contraceptive implant users requested premature removal due to irregular bleeding. Immediate postpartum implant insertion does not lead to increased removal rates and may help reduce unintended pregnancy. Mechanisms to help women manage irregular bleeding due to the implant are needed.

Implications

Immediate postpartum insertion of the etonogestrel contraceptive implant does not lead to increased removal rates due to vaginal bleeding compared to delayed postpartum or interval insertion. Immediate postpartum implant insertion may increase uptake of long-acting reversible contraception and help reduce short interpregnancy intervals and unintended pregnancy.     

Immediate postpartum initiation of etonogestrel-releasing implant: A randomized controlled trial on breastfeeding impact

BackgroundBreast milk volume has never been evaluated when the etonogestrel (ENG) implant was inserted immediately postpartum. Thus, this study evaluated if the immediate postpartum insertion of the ENG implant alters breast milk volume.Study designTwenty-four postpartum women and their newborns (NBs) were randomized into two groups: Implant group (ENG implant inserted within 48 h after delivery) and Control group (absence of contraceptive method). The primary outcome was the amount of breast milk intake by the NBs in the first 6 weeks after delivery. Five and ten grams of deuterium (D₂O) were orally administered to the postpartum women on the day of randomization (day 0) and on the 29th study day, respectively. Saliva samples were collected from the mother–NB pairs prior to each D₂O dose administration and after D₂O ingestion (periodic collection). The amount of breast milk ingested by the NBs was estimated by the amount of deuterium (D₂O) ingested by the NBs through breastfeeding, using mass spectrometry in the saliva samples.ResultsTwenty-four postpartum women and their NB were randomized (12 per group). The median of breast milk intake by NBs following the two D₂O doses were similar between groups {first D₂O dose [Implant: 340 mL/day (240–420 mL/day) vs. Control: 330 mL/day (300–530 mL/day), p=.54]; second D₂O dose [Implant: 845 mL/day (770–980 mL/day) vs. Control: 785 mL/day (680–980 mL/day), p=.63]}. The exclusive breastfeeding rate and NB weight were similar between groups in the first 6 weeks postpartum.ConclusionENG implant insertion immediately postpartum does not alter the volume of breast milk intake by NBs.ImplicationsConsidering the benefits of immediate postpartum initiation of ENG implant on reducing unintended pregnancy and pregnancy recurrence, especially in vulnerable populations, our study adds safety data on breastfeeding effect of this practice.     

Effects of initiating a contraceptive implant on subsequent condom use: A randomized controlled trial

ObjectiveTo evaluate whether initiation of a contraceptive implant, a method of long-acting reversible contraception, reduces condom use, as measured by a biomarker of recent semen exposure [prostate-specific antigen (PSA)].Study designWe conducted a randomized controlled clinical trial in which 414 Jamaican women at high risk for sexually transmitted infections (STIs) attending family planning clinics received the contraceptive implant at baseline (“immediate” insertion arm, N= 208) or at the end (“delayed” insertion arm, N= 206) of a 3-month study period. Participants were tested for PSA at baseline and two follow-up study visits and were asked about their sexual activity and condom use.ResultsAt baseline, 24.9% of women tested positive for PSA. At both follow-up visits, the prevalence of PSA detection did not significantly differ between the immediate versus delayed insertion arm [1-month: 26.1% vs. 20.2%, prevalence ratio (PR)=1.3, 95% confidence interval (CI)=0.9–1.9; 3-month: 25.6% vs. 23.1%, PR = 1.1, 95% CI=0.8–1.6]. The change in PSA positivity over the three study visits was not significantly larger in the immediate arm compared to the delayed arm (1-sided p-value of .15).ConclusionsContraceptive implants can be successfully introduced into a population at high risk of unintended pregnancy and STIs without a biologically detectable difference in unprotected sex in the short term. This information strengthens the evidence to support promotion of implants in such populations and can help refine counseling for promoting and maintaining use of condoms among women who choose to use implants.ImplicationsSex unprotected by a condom was not higher over 3 months in women receiving a contraceptive implant, compared with those not receiving the implant.     

Acceptability of a transdermal gel-based male hormonal contraceptive in a randomized controlled trial

Objective

Fifty percent of pregnancies in the United States are unintended despite numerous contraceptive methods available to women. The only male contraceptive methods, vasectomy and condoms, are used by 10% and 16% of couples, respectively. Prior studies have shown efficacy of male hormonal contraceptives in development, but few have evaluated patient acceptability and potential use if commercially available. The objective of this study is to determine if a transdermal gel-based male hormonal contraceptive regimen, containing testosterone and Nestorone® gels, would be acceptable to study participants as a primary contraceptive method.

Study Design

As part of a three-arm, 6-month, double-blind, randomized controlled trial of testosterone and nestorone gels at two academic medical centers, subjects completed a questionnaire to assess the acceptability of the regimen. Of the 99 men randomized, 79 provided data for analysis.

Results

Overall, 56% (44/79) of men were satisfied or extremely satisfied with this gel-based method of contraception, and 51% (40/79) reported that they would recommend this method to others. One third of subjects (26/79) reported that they would use this as their primary method of contraception if it were commercially available today. However, men with concerns about sexually transmitted disease were significantly less satisfied than men without such concerns (p=0.03).

Conclusions

A majority of the men who volunteered to participate in this trial of an experimental male hormonal contraceptive were satisfied with this transdermal male hormonal contraceptive. If commercially available, a combination of topical nesterone and testosterone gels could provide a reversible, effective method of contraception that is appealing to men.

Implications

A substantial portion of men report they would use this transdermal male contraceptive regimen if commercially available. This method would provide a novel, reversible method of contraception for men, whose current choices are limited to condoms and vasectomy.     

Computer-assisted motivational interviewing for contraceptive use in women leaving prison: A randomized controlled trial

ObjectivesRates of unintended pregnancies in women with a history of incarceration are high and access to contraception before and after arrest can be limited. Individualized counseling can better prepare women for healthy pregnancy or provide an opportunity for contraceptive education and access within correctional facilities. In this study, we assessed the efficacy of motivational interviewing as an individualized intervention to increase the initiation of contraceptive methods while incarcerated and continuation after release in female inmates who wanted to avoid pregnancy for at least one year after release.Study designWe performed an RCT in a population of incarcerated women who wanted to avoid pregnancy. Women were randomized to either a computer-assisted motivational interviewing intervention group (n = 119) or an educational video with counseling control group. (n = 113). The primary outcome was initiation of a method of birth control prior to release from the correctional facility.ResultsInitiation of contraception was higher in the intervention group (56% vs. 42%, p = 0.03), but this difference was not significant after controlling for number of male partners within the year prior to incarceration. There was no difference between the groups in the rates of pregnancies or STIs or continuation of contraception after release, which was generally low (21%).ConclusionComputer-assisted motivational interviewing did not improve uptake or continuation of contraception in this study.ImplicationsPeriods of incarceration provide an opportunity to offer contraceptive services to women who want to avoid a pregnancy. Motivational interviewing may not be an effective method to affect contraceptive behaviors in this population. Future research should explore the family planning values and preferences of women who become involved with the correctional system.     

Postplacental insertion of the levonorgestrel intrauterine device after cesarean delivery vs. delayed insertion: a randomized controlled trial

Objective

This trial was designed to compare levonorgestrel intrauterine device (LNG-IUD) use at 1 year after delivery between women randomized to postplacental insertion at the time of cesarean delivery and delayed insertion 4–8 weeks after delivery.

Study design

This randomized controlled trial was conducted at two urban medical centers. Eligible pregnant women with planned cesarean deliveries were randomized to immediate postplacental insertion during cesarean or delayed insertion after 4–8 weeks. We used intention-to-treat analysis for the primary outcome of LNG-IUD use 12 months after delivery.

Results

Forty-two women were randomized, 20 into the postplacental group and 22 in the delayed group. Although confirmed use of the LNG-IUD 12 months after delivery was higher in the postplacental group (60.0% vs. 40.9%, p=.35), this difference was not statistically significance. Expulsion was significantly more common in the postplacental group (20.0% vs. 0%, p=.04). There were significant differences between the two sites in baseline population characteristics, follow-up and expulsion. The trial did not answer the intended question as it was halted early due to slow enrollment.

Conclusions

Our results show higher expulsion after postplacental insertion compared to delayed insertion but suggest similar IUD use at 12 months. Moreover, it provides valuable lessons regarding a randomized controlled trial of postplacental LNG-IUD placement due to the challenges of estimating effect size and the nature of the population who might benefit from immediate insertion.

Implications

Postplacental insertion of an IUD may improve use of highly effective contraception during the postpartum period. While our results suggest higher expulsion after postplacental insertion compared to delayed insertion and similar IUD use at 12 months, our trial was insufficient to definitively test our hypothesis.     

Effects of zinc and magnesium supplements on postpartum depression and anxiety: A randomized controlled clinical trial

Postpartum anxiety and depression are prevalent disorders. The authors of this study aimed to determine the effects of zinc and magnesium supplements on depressive symptoms and anxiety in postpartum women referred to three governmental, educational hospitals in Tabriz, Iran during 2014–2015. In this triple-blind, randomized, controlled clinical trial, the participants were randomly assigned to the zinc sulfate, magnesium sulfate, and placebo groups (n = 33 per group). The intervention groups received a 27-mg zinc sulfate tablet or 320-mg magnesium sulfate tablet per day for 8 weeks, whereas the control group received a placebo tablet each day during the same period. The Edinburgh Postnatal Depression Scale and the Spielberger State-Trait Anxiety Inventory were completed before and 8 weeks after the intervention. Blood samples were drawn from each participant to determine serum levels of zinc and magnesium before intervention at 48 hours after delivery. Also, a 24-hour dietary questionnaire was used during the first and last 3 days of the intervention. Adjusting for baseline scores as well as zinc and magnesium serum levels, no significant difference was observed between groups 8 weeks after delivery in mean scores of depressive symptoms (p = .553), state anxiety (p = .995), and trait anxiety (p = .234). This study concluded magnesium and zinc did not reduce postpartum anxiety and depressive symptoms.     

Health and growth of infants breastfed by Norplant contraceptive implants users: a six-year follow-up study

The objective of the study was to evaluate safety to infants whose mothers used Norplant levonorgestrel implants during breastfeeding. A nonrandomized clinical trial design was used. Participants were 220 and 222 healthy breastfed infants of mothers initiating use of Norplant or T-Cu IUD, respectively, at 55 days to 60 days postpartum. Infants were followed from birth through age 6 years. Breastfeeding pattern, infant growth, and disease events were recorded monthly in the first year, three-monthly in the second, and annually thereafter. Most mothers continued use of Norplant (96.4%) and T-Cu (94.1%) during lactation, and 2140 months of infant exposure to levonorgestrel were accumulated. Breastfeeding pattern and infants growth, from admission through age 6 years, were similar in both groups. In the first year, breastfed infants in the Norplant group had higher incidence rates (p < 0.05) of mild episodes of respiratory infections (adjusted RR 1.17, CI 1.08-1.27), skin conditions (adjusted RR 1.46, CI 1.20-1.79), and eye infections (unadjusted RR 1.49, CI 1.03-2.18) than the control group. Later on, a higher proportion of infants in the T-Cu group showed neurological conditions. Although breastfeeding patterns and infant growth is not affected by Norplant use during lactation, the effect on infants' health of steroidal contraception should be further evaluated.     

Safety of the etonogestrel-releasing implant during the immediate postpartum period: a pilot study

Background

The effects of etonogestrel (ETG)-releasing contraceptive implant during the immediate postpartum period on maternal safety are unknown.

Study design

Forty healthy women exclusively breastfeeding were randomized to receive either ETG-releasing implant 24–48 h after delivery (n=20) or depot medroxyprogesterone acetate (DMPA group; n=20) at the sixth week postpartum. We measured blood pressure, maternal and neonatal weight, body mass index (BMI; kg/m²), waist circumference (WC), complete blood count, C-reactive protein, interleukin-6, tumor necrosis factor (TNF-alpha), lipid profile, fasting serum glucose and maintenance of exclusive lactation up to the 12th week postpartum.

Results

Decreases in mean maternal weight, BMI (kg/m²) and WC were significantly greater in the ETG-releasing implant group than in the DMPA group during the first 6 weeks postpartum (-4.64±2.71 kg vs. -2.6±2.45 kg mean±SD, p=.017; -1.77±1.06 kg/m² vs. -0.97±0.95 kg/m², p=.026; -15.3±6.72 cm vs. -9.05±5.84 cm, p=.003, respectively). In addition, total cholesterol and HDL, were lower in DMPA users, and TNF-alpha and leukocytes were higher in DMPA users compared to in the implant group, between 6 and 12 weeks after delivery. The newborns of implant users showed a trend towards gaining more weight, as compared with the infants of the DMPA mothers during the first 6 weeks of life (implant group: +1460.50±621.34 g vs. DMPA group: +1035.0±562.43 g, p=.05). The remaining variables, including the duration of exclusive breastfeeding, were similar between the groups.

Conclusion

The insertion of ETG-releasing contraceptive implant during the immediate postpartum period was not associated with deleterious maternal clinical effects or with significant maternal metabolic alterations or decreased infant weight gain.     

Effect of Lavender cream with or without footbath on sleep quality and fatigue in pregnancy and postpartum: a randomized controlled trial

Sleep disturbance and fatigue are frequent complaints during pregnancy and postpartum. We assessed the effectiveness of Lavender cream and footbath on sleep quality and fatigue in pregnancy and postpartum. In this trial, 141 women with sleep disturbance at 25–28 weeks gestation were recruited from public health centers in Tabriz, Iran, from May 2013 until January 2014 and randomized into one of three groups receiving: Lavender and footbath, Lavender alone, or placebo cream. Sleep quality was assessed using the Pittsburgh sleep quality index at the 4th and 8th weeks after intervention and the 6th week postpartum. Fatigue was assessed with the multidimensional assessment of fatigue scale at the 6th week after intervention and the 6th week postpartum. Repeated measures ANOVA and ANCOVA were used. Compared with the placebo group, the global sleep quality score post-intervention in pregnancy and the postpartum were significantly lower in the Lavender and footbath and the Lavender cream only groups. Fatigue in both intervention groups was significantly improved only at the 6th week postpartum. No statistically significant differences were observed between the two intervention groups. Lavender cream with or without footbath may improve sleep quality in pregnancy and postpartum.     

Efficacy of fennel and combined oral contraceptive on depot medroxyprogesterone acetate-induced amenorrhea: a randomized placebo-controlled trial

Objectives

We aimed to determine the efficacy of fennel and low-dose combined oral contraceptive (LD-COC) on inducing menstrual bleeding and method continuation in women using depot medroxyprogesterone acetate (DMPA) who had no menstrual bleeding within the previous 45 to 140 days.

Study design

In this double-blind double-dummy trial, 78 married women referred to public health centers in Hamadan, Iran, who complained of menstrual cessation induced by DMPA were randomly assigned into fennel, LD-COC or placebo groups with an allocation ratio of 1:1:1. All participants received two fennel or placebo capsules and one placebo or LD-COC pill daily for 21 days. We evaluated menstrual bleeding using the Higham pictorial chart within 40 days following initiating intervention. Data were analyzed using chi-square or analysis of variance.

Results

There was no loss to follow-up. Significantly more women in the fennel (73%) and LD-COC (81%) groups experienced menstrual bleeding compared to the placebo (19%) group [relative risk (RR) 3.1, 95% confidence interval (CI) 1.6 to 6.2; RR 4.2, 95% CI 1.9 to 9.4, respectively]. Mean amount of menstrual bleeding among those who experienced menstruation was significantly higher in the fennel group (21 cc) than both the LD-COC (14 cc) and placebo (12 cc) groups. Also, women using fennel (73%) and LD-COC (65%) were significantly more likely than those using placebo (31%) to have subsequent DMPA injection [RR 2.5 (95% CI 1.3 to 4.9) and RR 2.0 (95% CI 1.1 to 3.7), respectively].

Conclusions

Fennel and LD-COC can resolve DMPA-induced amenorrhea and increase continuation rate of this contraceptive method.     

Exposure to routine availability of immediate postpartum LARC: effect on attitudes and practices of labor and delivery and postpartum nurses

Objectives

Nurses play an integral role in intrapartum and postpartum patient education. This exploratory study aims to assess the attitudes, knowledge, and practices of labor and delivery and postpartum nurses regarding contraception and evaluate for changes in these measures 1 year after an institutional initiative allowing routine availability of immediate postpartum long-acting reversible contraception (LARC).

The effect of health and nutrition education intervention on women's postpartum beliefs and practices: a randomized controlled trial

Background  

'Sitting month' is the Chinese tradition for postpartum customs. Available studies indicate that some of the traditional postpartum practices are potentially harmful for women's health. However, no intervention study aiming at postpartum practices has been performed. In this paper we evaluated the effect of a health and nutrition education intervention, which focused on improving postpartum dietary quality and optimal health behaviors.     

Ethinyl estradiol and levonorgestrel pharmacokinetics with a low-dose transdermal contraceptive delivery system, AG200-15: a randomized controlled trial

BackgroundThis study evaluated the ethinyl estradiol (EE) and levonorgestrel (LNG) pharmacokinetic profiles of AG200-15, a transdermal contraceptive delivery system, compared with a combination oral contraceptive (COC) containing EE 35 mcg and norgestimate 250 mcg.Study designA Phase 1, open-label, single-center study in 36 healthy women was conducted over three cycles with a randomized crossover design. After a run-in cycle of 21 days on and 7 days off with AG200-15, participants were randomized to receive one of two treatments: a 21/7-day cycle of AG200-15 either followed or preceded by one cycle of the COC. This trial is registered on ClinicalTrials.gov under the identifier NCT01243580.ResultsDuring the third week of AG200-15 use, mean (±standard deviation) maximum serum concentration (C_max), area under the curve_{0–168 h} and steady-state concentration (C_{ss48–168 h}) for EE were 51.3±17.3 pg/mL, 6.26±2.46 ng h/mL and 35.7±14.5 pg/mL, respectively; for LNG, the corresponding values were 2400±1140 pg/mL, 317±159 ng h/mL and 1847±930 pg/mL, respectively. The AG200-15 EE C_max was approximately 60% lower and the EE C_ss was 15%–20% lower than those obtained with the COC. The calculated daily dose of AG200-15 was equivalent to a 30-mcg EE COC. The most common adverse events (AEs; >10%) in the AG200-15 group were headache, nausea and application-site irritation. All drug-related AEs were mild, and no serious AEs were reported.ConclusionsEE and LNG daily exposure during AG200-15 treatment was within the range reported for a low-dose COC. The daily EE dose with AG 200-15 was equivalent to a 30-mcg COC and was safe and well tolerated.     

Conformity with current guidelines on oral contraceptive prescribing for breastfeeding women: a New Mexico survey

BACKGROUND: National and international contraceptive guidelines reflect expert opinion that recommends against the use of estrogen-containing hormonal contraception in the early postpartum period. This study was undertaken to estimate providers' practices in prescribing hormonal contraception to breastfeeding women. METHODS: A 19-item survey was mailed to 397 obstetrician gynecologists, midwives and family physicians in the state of New Mexico. The survey included items covering attitudes about the impact of hormonal contraception on breastfeeding and prescribing practices. One hundred ninety-nine (50%) providers completed the survey. RESULTS: The majority (70%) of providers prescribe progestin-only contraceptive methods to breastfeeding women within the first 6 weeks. Despite these recommendations, a sizable minority of providers prescribe combined pills in the early postpartum period: 27% of providers have prescribed combined pills and 13% of providers, mostly those in a university setting, routinely recommend them within the first 6 weeks postpartum. CONCLUSION: Most providers follow expert recommendations regarding the initiation of hormonal contraception for breastfeeding women.