Safety, effectiveness and acceptability of misoprostol for treatment of incomplete mid trimester abortion in Uganda

Abstract

Eight percent of the maternal deaths in Uganda are abortion-related and yet women still have limited access to quality postabortion care. Task sharing is a proposed strategy to increase access to safe postabortion care and family planning. However, there is a paucity of data on task sharing in postabortion care in the second trimester as well as staff and patients’ experiences and acceptability. With a view to address the knowledge gaps and inform policy, we aimed to compare the safety, effectiveness and acceptability of medical treatment for incomplete second trimester abortion by midwives and physicians in Uganda, including postabortion family planning. To determine abortion-related near-miss and mortality by sociodemographic risk factors and management options by pregnancy trimester in Uganda. (Study I) 2. To compare the effectiveness and safety of treatment outcomes for incomplete second trimester abortion using misoprostol when provided by midwives versus physicians in Uganda. (Study II) 3. To explore health care providers’ experiences of and perceptions towards the use of misoprostol for management of second trimester incomplete abortion. (Study III) 4. To compare women’s acceptability of second trimester postabortion care using misoprostol by either midwives or physicians. (Study IV) 5. To assess postabortion family planning uptake and its associated factors among women with second trimester incomplete abortion. (Study V). Study I was a secondary data analysis that used an adapted World Health Organization near-miss methodology to collect cross-sectional maternal near-miss and abortion complications data at 43 health facilities in Central and Eastern Uganda from 2016 - 2017. We computed abortion severe morbidity, near-miss, and mortality ratios per 100,000 live-births; proportion of cases that worsened to an abortion near-miss or death; association between second trimester near-miss and independent demographic and management indicators; and assessed health facility readiness comparing the two regions. Study II was a multi-centre randomized controlled equivalence trial at 14 public health facilities in Central Uganda that recruited women with incomplete abortion of uterine size 13-18 weeks. We randomly assigned women to clinical assessment and treatment by either a midwife or physician in a ratio of 1:1. Participants received sublingual misoprostol 400mcg three-hourly up to five doses. Primary outcome was complete abortion within 24 hours that did not require surgical evacuation. Analysis was per-protocol and intention to treat. Study IV used mixed methods to measure acceptability at the 14-day follow-up visit in addition to 28 patient in-depth interviews. Study V was a cross-sectional survey of study II participants and the primary outcome was postabortion family planning uptake within two weeks of treatment. In study III, we conducted 48 in-depth interviews for physicians and midwives participating in the trial. Qualitative studies III and IV used the phenomenological approach, flexible interview guides, and inductive content analysis. Quantitative studies II, IV and V used interviewer administered questionnaires and analysis was by mixed effects generalized linear models to obtain risk differences and risk ratios for study I. Of 3315 recorded severe abortion morbidity cases, 1507 were near-misses (study I). Severe abortion morbidity, near-miss, and mortality ratios were 2063, 938, and 23 per 100,000 livebirths respectively. Abortion-related mortality ratios were 11 and 57 per 100,000 live-births in Central and Eastern regions, respectively. Abortion near-miss cases were significantly associated with referral (p< 0.001). Second trimester abortion had greater mortality compared to first trimester. Eastern region had greater abortion-related morbidity and mortality than Central region with facilities in the former characterized by inferior readiness to provide postabortion care. From 14th August 2018 to 16th November 2021, we assessed 7190 women for eligibility and randomized 1191 (593 to midwife and 598 to physician) in study II. Of the 1164 women in the outcome analysis, 530 women (91.9%) in the midwife’s arm and 553 (94.2%) in the physician’s arm had a complete abortion within 24 hours. The model-based risk difference for midwife versus physician group was –2.3% (95% CI –4.4 to -0.3), and within our predefined equivalence range of –5% to +5%. Two women in the midwife’s group received blood transfusion. We successfully followed up 1140 women and 1071 (94%) indicated that the procedure was very acceptable to them in study IV. The adjusted risk difference was 1.2% (95% CI, -1.2% to 3.6%) between the two groups, and within our predefined equivalence range of –5% to +5%. Treatment success and feeling calm and safe after treatment enhanced satisfactory acceptability while experience of side effects and worrying bleeding patterns reduced satisfaction. In study III, health care providers perceived well trained midwives as competent to manage second trimester postabortion care stable patients, however physician’s supervision in case of complications was considered important. Sometimes, midwives were seen as offering better care than physicians given their stronger presence in the facilities. Misoprostol received unanimous support and was viewed as: safe, effective, cheap, convenient, readily available, maintained patient privacy, and saved resources. Challenges faced included: side effects, prolonged hospital stay, treatment failure, inclination to surgical evacuation, heavy work load, inadequate space, lack of medical commodities, frequent staff rotations which affects the quality of patient care. To address these challenges, respondents coped by: giving patients psychological support, analgesics, close patient monitoring, staff mentorship, commitment to work, team work, and patient involvement in care. Second-trimester postabortion family planning uptake in study V was 65.6%. Implants (37.5%) and progestin only injectables (36.5%) were the commonly chosen methods. 45.2% of the women who declined family planning desired another pregnancy soon. Women whose spouses were aware of the pregnancy or had planned pregnancy had 11% (-10.5%, 95% CI -17.1 to -3.8) and 12% (-11.7%, 95% CI -19.0 to -4.4) less uptake compared to women whose spouses were not aware of the pregnancy or those with unplanned pregnancies respectively. Uptake was 8% (-7.8%, 95% CI -12.6% to -3.0%) lower among Islamic women compared to Anglicans. Women who received postabortion family planning counselling or had more than four live births had 59% (59.4%, 95% CI 42.1 to 76.7) and 13% (13.4%, 95% CI 4.0% to 22.8%) more uptake compared to women who did not receive counselling or women with no live births, respectively Uganda has a major burden of abortion near-miss morbidity and mortality; with mortality higher in the second trimester. Life-saving commodities are lacking especially in Eastern region compromising health facility readiness for postabortion care provision. Clinical assessment and treatment of second trimester incomplete abortion using misoprostol was equally effective, safe, and highly acceptable when provided by midwives compared to physicians. The uptake of second-trimester post-abortion family planning in Uganda was higher than previous estimates. Postabortion family planning counselling, grand multiparity, and need to avoid an unplanned pregnancy increased contraceptive utilization. In settings that lack adequate staffing levels of physicians or where midwives are available to provide misoprostol, task sharing second trimester medical postabortion care with midwives increases patient’s access to care. Health care providers require institutional and policy environment support for improved service delivery. Ministry of Health should strengthen post-abortion family planning counselling, especially couple counselling; at all health facilities in the country and also ensure an adequate and accessible supply of a wide contraceptive method mix.