Dalia Brahmi

Pregnancy outcomes with an IUD in situ: a systematic review

BACKGROUND While intrauterine devices (IUDs) provide highly effective contraception, pregnancies among IUD users do rarely occur. The objective of this systematic review is to assess the evidence about risks for adverse pregnancy outcomes among women who conceive with an IUD in situ. METHODS We searched MEDLINE, POPLINE, EMBASE and LILACS databases from inception through April 2011 for peer-reviewed articles containing evidence related to pregnancy outcomes among women who conceived while using copper (Cu) and levonorgestrel-releasing (LNG) IUDs. RESULTS Nine articles met our inclusion criteria. Women with retained IUDs were at the greatest risk of adverse pregnancy outcomes, including spontaneous abortion, preterm delivery, septic abortion and chorioamnionitis. Cu-IUD removal decreased risks but not to the baseline risk of pregnancies without an IUD. One case series examined the LNG-IUD; when left in situ, 8 in 10 ended in spontaneous abortions. CONCLUSION Pregnancies complicated by a remaining IUD in situ were at greater risk of adverse pregnancy outcomes. Early IUD removal appeared to improve outcomes but did not entirely eliminate risks.

Who can provide effective and safe termination of pregnancy care? A systematic review*.

Background  Unsafe termination of pregnancy is a major contributor to maternal morbidity and mortality. Task sharing termination of pregnancy services between physicians and mid‐level providers, a heterogeneous group of trained healthcare providers, such as nurses, midwives and physician assistants, has become a key strategy to increase access to safe pregnancy termination care.

A review of evidence for safe abortion care

BACKGROUND The provision of safe abortion services to women who need them has the potential to drastically reduce or eliminate maternal deaths due to unsafe abortion. The World Health Organization recently updated its evidence-based guidance for safe and effective clinical practices using data from systematic reviews of the literature. MATERIALS AND METHODS Systematic reviews pertaining to the evidence for safe abortion services, from pre-abortion care, medical and surgical methods of abortion and post-abortion care were evaluated for relevant outcomes, primarily those relating to safety, effectiveness and womens preference. RESULTS Sixteen systematic reviews were identified and evaluated. The available evidence does not support the use of pre-abortion ultrasound to increase safety. Routine use of cervical preparation with osmotic dilators, mifepristone or misoprostol after 14 weeks gestation reduces complications; at early gestational ages, surgical abortions have very few complications. Prophylactic antibiotics result in lower rates of post-surgical abortion infection. Pain medication such as non-steroidal anti-inflammatories should be offered to women undergoing abortion procedures; acetaminophen, however, is not effective in reducing pain. Women who are eligible should be offered a choice between surgical (vacuum aspiration or dilation and evacuation) and medical methods (mifepristone and misoprostol) of abortion when possible. Modern methods of contraception can be safely initiated immediately following abortion procedures. CONCLUSIONS Evidence-based guidelines assist health care providers and policymakers to utilize the best data available to provide safe abortion care and prevent the millions of deaths and disabilities that result from unsafe abortion.

Effect of missed combined hormonal contraceptives on contraceptive effectiveness: a systematic review.

BACKGROUND Combined hormonal contraceptives (CHCs) are popular methods of reversible contraception in the United States, but adherence remains an issue as reflected in their lower rates of typical use effectiveness. The objective of this systematic review was to evaluate evidence on the effect of missed CHCs on pregnancy rates as well as surrogate measures of contraceptive effectiveness (e.g., ovulation, follicular development, changes in hormone levels, cervical mucus quality). STUDY DESIGN We searched the PubMed database for peer-reviewed articles published in any language from database inception through April 2012. We included studies that examined measures of contraceptive effectiveness during cycles with extended hormone-free intervals or nonadherence (e.g., omission of pills, delayed patch replacement) on days not adjacent to the hormone-free interval. We used standard abstract forms and grading systems to summarize and assess the quality of the evidence. RESULTS The search strategy identified 1387 articles, of which 26 met our study selection criteria. There is wide variability in the amount of follicular development and risk of ovulation among women who extended the pill-free interval to 8-14 days; in general, the risk of ovulation was low, and among women who did ovulate, cycles were usually abnormal (i.e., low progesterone levels, small follicles and/or poor cervical mucus) (Level I, good, indirect to Level II-3, fair, indirect). Studies of women who missed one to four consecutive pills or 1-3 consecutive days of delay before patch replacement at times other than adjacent to the hormone-free interval reported little follicular activity and low risk of ovulation (Level I, fair, indirect to Level II-3, poor, indirect). Studies comparing 30 mcg versus 20 mcg mc ethinyl estradiol pills showed more follicular activity when 20 mcg ethinyl estradiol pills were missed (Level I, good, indirect). CONCLUSION Most of the studies in this evidence base relied on surrogate measures of pregnancy risk and ranged in quality. For studies providing indirect evidence on the effects of missed CHCs, it is unclear how differences in surrogate measures correspond to pregnancy risk. Fewer studies examined the transdermal patch and vaginal ring than combined oral contraceptives.

Appropriate follow up to detect potential adverse events after initiation of select contraceptive methods: a systematic review

BACKGROUND After a woman initiates certain methods of contraception [e.g., hormonal methods, intrauterine devices (IUDs)], she is generally asked to return at some interval for a follow-up visit; however, is it unclear whether follow up is needed, what an appropriate follow-up schedule is and what should be done at follow-up visits. METHODS We conducted four separate searches in the PubMed database for all peer-reviewed articles in any language published from database inception through April 2012 that examined the following health outcomes for combined hormonal contraceptives (CHCs), IUDs or medroxyprogesterone acetate (DMPA): (a) incidence of hypertension among women who began using a CHC compared to women not using a CHC; (b) incidence of migraine among women who began using a CHC compared to women not using a CHC; (c) incidence of pelvic inflammatory disease (PID) among women who began using an IUD compared to women who started another form or used no method of contraception or examined incidence of PID at two or more time periods after IUD insertion and (d) whether initial weight gain predicts future weight gain among women who began using DMPA. The quality of each study was assessed using the United States Preventive Services Task Force grading system. RESULTS A total of 15 studies met our inclusion criteria: 5 examined hypertension and combined oral contraceptive (COC) use, 7 examined PID and IUD use and 3 examined weight gain after DMPA initiation. No studies that examined migraine after CHC initiation met our inclusion criteria. Few women developed hypertension after initiating COCs, and studies examining increases in blood pressure after COC initiation found mixed results (Level I, fair to II-2, fair). Among women who had a copper IUD inserted, there was little difference in incidence of PID, or IUD removal for PID, compared with women who initiated DMPA, a hormone-releasing IUD, or COCs (Level I, good to Level II-2, fair). Studies that examined when women were diagnosed with PID after IUD insertion found mixed results. The study with the largest sample size found a much greater incidence of PID in the first 20 days after insertion, with very low rates of PID up to 8 years postinsertion (Level I, good to Level II-3, poor). Studies that examined weight gain after DMPA initiation found that weight gain >5% of baseline weight at 6 months was associated with greater mean change in weight and greater mean change in body mass index at follow-up times ranging from 12 to 36 months (Level II-2, fair to Level II-3, fair). CONCLUSIONS Evidence on select adverse events associated with initiation of contraceptive use is limited but does not suggest increased risk of hypertension among COC users or increased risk of PID among IUD users. DMPA users who gain >5% of baseline body weight may be at increased risk of future weight gain.

Standardizing abortion research outcomes (STAR): a protocol for developing, disseminating and implementing a core outcome set for medical and surgical abortion

Author(s): Whitehouse, Katherine C; Kim, Caron R; Ganatra, Bela; Duffy, James MN; Blum, Jennifer; Brahmi, Dalia; Creinin, Mitchell D; DePineres, Teresa; Gemzell-Danielsson, Kristina; Grossman, Daniel; Winikoff, Beverly; Gulmezoglu, A Metin

When can a woman start combined hormonal contraceptives (CHCs)?: a systematic review

BACKGROUND Conventional methods of initiating combined hormonal contraceptives (CHCs), specifically combined oral contraceptives (COCs), the contraceptive patch and the contraceptive ring, require that women delay starting CHCs until menses begin, during which time a woman may be at risk of unintended pregnancy. The objective of this systematic review is to examine the evidence on the risk of becoming pregnant after starting the method (contraceptive effectiveness including surrogate measures such as ovarian follicular development and hormone levels), risk of already being pregnant, side effects and continuation when starting CHCs on different days of the menstrual cycle. STUDY DESIGN We searched the MEDLINE database for all articles (in all languages) published in peer-reviewed journals from inception through March 2012 for evidence relevant to starting CHCs on different days of the menstrual cycle and the outcomes of contraceptive effectiveness (including ovarian follicular development and hormonal levels), side effects and continuation rates. RESULTS From 1635 reviewed articles, 18 studies met our inclusion criteria. Evidence from four studies suggests that neither the risk of inadvertently starting COCs in a woman who is pregnant nor the risk of pregnancy after COC initiation are affected by the cycle day on which COCs are started. While follicular activity increased as the cycle day on which COCs were initiated increased, no women ovulated when starting on Day 5. When starting on Day 7, there was no increase in ovulation for a 30-mcg pill but a significant increase in ovulation with a 20-mcg pill compared with starting on Day 1. Evidence from two small studies suggests that 7 days of pills leads to inhibition of ovulation. One small study suggests that only 3 days of ring use is needed to inhibit ovulation, but this was following one complete treatment cycle of ring use. Evidence also suggests that starting CHCs on any day of the cycle does not affect bleeding problems or other side effects for both COCs and the patch. While starting CHCs via Quick Start (starting on the day of the health care visit) may initially increase continuation compared with more conventional starting strategies, evidence suggests that this difference disappears over time. CONCLUSION The body of evidence suggested that (a) pregnancy rates did not differ by the timing of CHC initiation; (b) the more follicular activity that occurred prior to starting COCs, the more likely ovulation was to occur; however, no ovulations were seen when COCs were started at a follicle diameter of 10 mm (mean cycle day=7.6) or when the ring was started at follicle diameter of 13 mm (median cycle day=11); (c) bleeding patterns and other side effects did not vary with the timing of CHC initiation and (d) continuation rates of CHCs were initially improved by Quick Start, but differences between groups disappeared over time.

The effect of follow-up visits or contacts after contraceptive initiation on method continuation and correct use.

BACKGROUND We conducted a systematic review to assess whether follow-up visits or contacts after a woman begins using contraception improve method continuation and correct use. STUDY DESIGN We searched the PubMed database for all peer-reviewed articles in any language published from database inception through May 2012 that examined the effect of a structured follow-up schedule of visits or contacts on contraceptive use. We included studies that compared women who initiated a method of contraception with a certain follow-up schedule compared to women with a different follow-up schedule or no follow-up at all. To be included, studies must have compared groups on a measure of contraceptive use (e.g., pregnancy, correct use, consistent use, method discontinuation including expulsion). Though not ideally suited to answer our review question, studies in which women used a variety of contraceptive methods but results were not stratified by method type were included. RESULTS Four studies met our inclusion criteria (Level I, poor to II-2, poor). Two studies examined the effect of a specific follow-up visit schedule on intrauterine device (IUD) continuation: one examining frequency of visits and one examining the timing of the first follow-up visit. Women with more frequent follow-up visits did not have a statistically significant difference in proportion of removals for medical reasons compared with women who had fewer follow-up visits; among women who had their IUDs removed for medical reasons, those who had more frequent follow-up visits had a longer mean time of use prior to removal. The other study found more removals and shorter continuation among women with a follow-up visit at 1 week compared to women with a follow-up visit at 1 month after IUD insertion (no statistical tests reported). Two studies examined the effect of follow-up phone calls compared to no follow-up phone calls after an initial family planning visit among adolescents initiating a variety of contraceptive methods. Neither of the two studies found any differences in method continuation or correct use between study groups. CONCLUSIONS It is difficult to determine what effect, if any, follow-up visits or contacts have on contraceptive method continuation or correct use. Few studies were identified, and those that were identified were mostly of poor quality, were not method specific and had either poor patient compliance with follow-up visits or poor phone contact completion rates.

What contraception do women use after abortion? An analysis of 319,385 cases from eight countries

ABSTRACT Contraception is an essential element of high-quality abortion care. However, women seeking abortion often leave health facilities without receiving contraceptive counselling or methods, increasing their risk of unintended pregnancy. This paper describes contraceptive uptake in 319,385 women seeking abortion in 2326 public-sector health facilities in eight African and Asian countries from 2011 to 2013. Ministries of Health integrated contraceptive and abortion services, with technical assistance from Ipas, an international non-governmental organisation. Interventions included updating national guidelines, upgrading facilities, supplying contraceptive methods, and training providers. We conducted unadjusted and adjusted associations between facility level, client age, and gestational age and receipt of contraception at the time of abortion. Overall, postabortion contraceptive uptake was 73%. Factors contributing to uptake included care at a primary-level facility, having an induced abortion, first-trimester gestation, age ≥25, and use of vacuum aspiration for uterine evacuation. Uptake of long-acting, reversible contraception was low in most countries. These findings demonstrate high contraceptive uptake when it is delivered at the time of the abortion, a wide range of contraceptive commodities is available, and ongoing monitoring of services occurs. Improving availability of long-acting contraception, strengthening services in hospitals, and increasing access for young women are areas for improvement.

A research agenda for moving early medical pregnancy termination over the counter

Given the overall safety profile and increasing availability of medical pregnancy termination drugs, we asked: would the mifepristone–misoprostol regimen for medical termination at ≤10 weeks of gestation meet US Food and Drug Administration regulatory criteria for over‐the‐counter (OTC) approval, and if not, what are the present research gaps? We conducted a literature review of consumer behaviours necessary for a successful OTC application for medical termination at ≤10 weeks of gestation and identified crucial research gaps. If we were to embark on a development programme for OTC or more generally, self‐use of medical termination, the critical elements missing are the label comprehension, self‐selection and actual use studies.