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Background: Obstetric fistula (OF) is a maternal morbidity associated with high rates of stillbirth, amenorrhea, and sexual dysfunction. Limited data exists on the reproductive outcomes of women in the years following a fistula repair. The objective of this study is to describe the fertility outcomes and family planning practices in a population of Malawian women 1-4 years after fistula repair. Methods: Women who had enrolled into a clinical database of OF patients and undergone OF repair between January 1, 2012 and July 31, 2014 were recruited and enrolled to complete a home-based survey of their demographic and reproductive health data 1-4 years after their repair. Pregnancy, amenorrhea, and sexual function were described using frequency analysis, and we compared antimüllerian hormone (AMH) concentrations between women with menses or pregnancy with women with amenorrhea or no pregnancy using Wilcoxon rank sum tests. Results: Of 297 women with a prior OF repair, 148 had reproductive potential and were included in this analysis. Overall 30 women of these women (21%) became pregnant since their fistula repair, with most pregnancies ending with cesarean delivery. Of the 32 women who were amenorrheic at the time of repair, 25 (78.1%) had resumption of menses. Only 11 (8.6%) of sexually active women reported dyspareunia, and among women who were not trying to conceive, 53.1% were currently using a method of family planning. No significant differences were found in AMH concentrations between those who were pregnant or had menses versus those without pregnancy or menses, respectively. Conclusions: In this long-term follow-up study of women after OF repair, many women were able to achieve a pregnancy with a live birth, have normal menses, be sexually active, and access contraception. These achievements will further assist a population of women whose reintegration and restoration of dignity is closely tied to their ability to achieve their reproductive goals. Trial registration: ClinicalTrials.gov Identifier: NCT02685878.
This study recruited women who had undergone OF repair at the Freedom from Fistula Foundation Fistula Care Centre at Bwaila Hospital in Lilongwe, Malawi. The Fistula Centre receives referrals from all regions of Malawi, as well as western Mozambique and eastern Zambia. Women presenting to the Fistula Care Centre with a confirmed OF are consented for enrollment into a clinical database that includes demographic data, physical exam findings, surgical procedures, post-operative findings (including a post-operative 1-h pad test prior to discharge), and information from three follow-up visits (at months 1, 3, and 12) to the Fistula Care Centre in the first year after repair. Women were eligible for recruitment for this long-term follow-up study if they: (1) had a history of OF repair at the Fistula Care Centre between January 1, 2012 and July 31, 2014 and were enrolled in the database (2) spoke Chichewa (the local language) or English fluently, (3) were age 18 years or above, (4) were currently living in districts in Malawi within 4 h drive of the Fistula Care Centre by motorcycle and (5) were alive at the time of recruitment for this follow-up study. Eligible women identified from the clinical database were traced, recruited, consented, and enrolled in their homes during a visit from a non-medical staff member. We elected to trace women and interview them in their home villages due to the relatively low proportion that return to the Fistula Care Centre for follow-up after their repair (only 20% return for their 12-month follow-up visits). Women who were traced provided informed consent and completed a survey of demographic, obstetric and gynecologic history, human immunodeficiency virus (HIV) status and testing history and validated measures of quality of life and depressive symptoms [14, 15]. Some of the women traced had not completed any clinical follow-up since their repair. Ethical approval was obtained from the National Health Sciences Research Committee of Malawi (protocol #15/5/1428) and the University of North Carolina School of Medicine Institutional Review Board (Study # 15–0972). The research protocol was registered on clinicaltrials.gov (Identifier: {“type”:”clinical-trial”,”attrs”:{“text”:”NCT02685878″,”term_id”:”NCT02685878″}}NCT02685878). Trained research assistants double-entered and compared the data using REDCap (Research Electronic Data Capture, NC) [16]. Participants’ demographic information, reproductive information, and HIV testing were self-reported. A convenience subset of women included in this analysis had had pelvic ultrasonography performed and hormone markers drawn (AMH, follicle-stimulating hormone [FSH], and estradiol at the time of fistula repair, as a part of another study) [10]. Blood samples were sent to the UNC Project-Malawi Laboratory, where they were centrifuged. Serum was then aliquoted into 1.0 mL cryovials and stored in cryoboxes at −80°C until they were shipped in batches on dry ice to the University of Southern California Reproductive Endocrinology Research Lab. AMH was measured primarily by use of the Ultrasensitive AMH ELISA kit (Ansh Labs, Webster, TX). The picoAMH ELISA kit (Ansh Labs) was used when AMH values were below the limit of detection (<0.07 ng/ml) of the Ultrasensitive ELISA. The limit of detection of the picoAMH ELISA is 0.003 ng/ml. FSH and estradiol was measured by direct immunoassay on the Immulite analyzer (Siemens Healthcare Diagnostics, Deerfield, IL). Hypergonadotropic gonadism was defined as FSH ≥10.0 mIU/ml and Estradiol <20.0 pg/ml. Reproductive potential was determined after excluding women who were postmenopausal by self-report as their reason for amenorrhea or 50 years or older at the time of the study. Women were also excluded if they had previously undergone hysterectomyor bilateral tubal ligation (in Malawi, bilateral tubal ligations are irreversible, so women who had undergone this surgery could not become pregnant again). Pregnancy, amenorrhea, and sexual function were described using frequency analysis, and Kaplan-Meier estimates were used to calculate the incidence rate for pregnancy. Wilcoxon rank sum tests and linear regression models adjusted for age were used to compare AMH concentrations between: 1) women who became pregnant versus those who did not become pregnant, and 2) women had menses resume and those who did not resume menses. All data were analyzed using Stata Version 13.0 (StataCorp, College Station, TX).
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