"Suction Tube Uterine Tamponade" for treatment of refractory postpartum hemorrhage: Internal feasibility and acceptability pilot of a randomized clinical trial.

OBJECTIVE: To assess feasibility and acceptability of a novel, low-cost "Suction Tube Uterine Tamponade" (STUT) treatment for refractory postpartum hemorrhage (PPH). METHODS: We allocated patients with refractory PPH by randomly ordered envelopes to STUT or routine uterine balloon tamponade (UBT, Ellavi free-flow system) in 10 hospitals in South Africa. In the STUT group, a 24FG Levin stomach tube was inserted into the uterine cavity and vacuum created with a vacuum pump or manual vacuum aspiration syringe. RESULTS: For this internal pilot study, 12 participants were allocated to STUT and 12 to UBT. Insertion failed in one of each group and was recorded as difficult in 3/10 STUT and 4/9 UBT insertions respectively (five missing data). There were two laparotomies and one intensive care unit admission in the UBT group. Pain during STUT insertion was graded as none/mild in 9/10 and severe in 1/10. The experience of the STUT procedure was graded as fine in 4/11 and "uncomfortable but acceptable" in 7/11. CONCLUSION: STUT is feasible and acceptable, justifying continuation of our trial. These data will also inform a large World Health Organization trial to test effectiveness of uterine tamponade methods. The numbers are too small to support any clinical recommendation.

Foley Catheter Tourniquet for Uncontrollable Extra-Uterine Placental Hemorrhage: Description of a Novel Surgical Technique.

INTRODUCTION: Hemorrhage from a partially or fully detached placenta with an advanced abdominal pregnancy can be profuse and catastrophic. The general approach to placental management is removal of "all or nothing." In the event of acute hemorrhage, attempts to achieve hemostasis quickly are critical. We have found a Foley catheter tourniquet to be useful to control placental hemorrhage or as a temporary tourniquet applied around structures surrounding the implantation site to aid placental removal. We report use of the technique on 4 occasions with good surgical outcomes. CASE PRESENTATION: We report the case of a 33-year-old primigravid woman admitted at term with ultrasound diagnosis of breech presentation and placenta previa grade 4. Her preoperative clinical assessment, however, raised suspicion of an abdominal pregnancy. At laparotomy, a live female infant was delivered from the extra-uterine gestation sac, weighing 3,640 g and with Apgar scores of 7 and 6 at 1 and 5 min, respectively. Following delivery, there was profuse bleeding from the partially detached distal portion of the placenta that derived a rich blood supply from the poorly accessible posterior pelvic wall. We applied a novel, simple, and effective surgical technique for minimizing blood loss from the partially detached placenta using a Foley's catheter tourniquet that was applied between the detached and still attached parts of the placenta. The tourniquet was left in situ and removed at laparotomy 4 days later. The placenta was not removed. The mother and baby did well postoperatively and were discharged after 10 and 21 days, respectively, in good condition. The surgical technique was used in 3 additional cases with good clinical outcomes. DISCUSSION: Use of a Foley catheter as an intraoperative tourniquet has become accepted as a useful technique in obstetric and gynecological surgery. We describe a simple life-saving technique of applying a Foley tourniquet across a partially detached placenta following an advanced extra-uterine pregnancy to control acute hemorrhage. CONCLUSION: We recommend that surgeons keep in mind the option of intraoperative tourniquets when faced with uncontrollable bleeding as a short-term or medium-term temporizing measure.

Birth defects following exposure to efavirenz-based antiretroviral therapy during pregnancy: a study at a regional South African hospital.

OBJECTIVES: To determine the prevalence and type of birth defects among infants following exposure to efavirenz-based antiretroviral therapy (EFV-based ART) during pregnancy. METHODS: A Pregnancy Registry was established to enable prospective follow-up of women taking EFV-based ART. In women who conceived on EFV-based ART, EFV was switched with another drug if they presented during the first trimester but was continued if they presented at or after 14 weeks' gestation. Pregnant women needing lifelong ART were commenced on EFV-based ART from 14 weeks' gestation onwards. Infants were followed up for 6 weeks after birth. RESULTS: Between January 2006 and December 2008, 623 ART-naive pregnant women initiated EFV-based ART in the second/third trimester and 195 women conceived on EFV-based ART. Birth defects were observed in 16 of 623 live births [2.6%; 95% confidence interval (CI) 1.5-4.2] and in six of 184 live births (3.3%; 95% CI 1.2-7.0) from women exposed to EFV in the second/third trimester and first trimester, respectively. The prevalence of birth defects was not significantly different between the first and second/third trimester EFV exposure (prevalence ratio 1.27; 95% CI 0.50-3.20; P = 0.301). CONCLUSION: No significant increase in the prevalence of birth defects following exposure to EFV-based ART in the first trimester was observed in this cohort. However, the limited number of first trimester EFV-exposed infants precludes definitive conclusions on the teratogenicity or safety of EFV.