Preliminary efficacy, feasibility and safety of intra-umbilical oxytocin to reduce the time to placental delivery at caesarean section: an exploratory randomized trial.

Background: Delayed placental separation either after vaginal birth or caesarean birth is an important cause of postpartum haemorrhage, among other causes such as uterine atony. Intra-umbilical oxytocin has been shown to reduce the time to placental delivery after vaginal birth. However, the efficacy of intra-umbilical oxytocin to reduce the time to placental delivery following caesarean section birth is not known. Objectives: To explore the preliminary efficacy, feasibility and safety of intra-umbilical oxytocin to reduce the time to placental delivery at caesarean section. Methods: A double-blind, placebo-controlled, exploratory randomized clinical trial was conducted at a tertiary hospital in the Eastern Cape Province, South Africa. A total of 66 women undergoing elective caesarean section were enrolled in the study and randomized into oxytocin group (n = 33) receiving an intra-umbilical infusion of 20 units of oxytocin in 30ml saline, and placebo group (n = 33) receiving an intra-umbilical infusion of 30ml saline. Data were analysed using Epi Info and RevMan software. Preliminary efficacy was assessed by examining the time elapsed from birth of the baby to complete delivery of the placenta; blood loss more than 500 ml; the need for manual removal of the placenta; and the completeness of the placenta. Feasibility was determined by observing the successful insertion of the catheter and injection of the solution. Safety was evaluated by investigating adverse effects of the procedure. Results: Four women (12%) in the placebo group had a delayed placental delivery compared to one (3%) in the oxytocin group. The mean time from birth to placental delivery was 159 (SD 61) seconds in the placebo group and 143 (SD 45) seconds in the oxytocin group. There was no statistically significant difference between the two groups. Feasibility of the procedure was confirmed by successful insertion of the catheter and injection of the majority of the solution in all 66 cases. No adverse effects of the procedure were identified. Conclusion: Administration of intra-umbilical oxytocin is feasible, safe and has potential to reduce the time of placental delivery at caesarean section. Further studies involving larger sample sizes are justified.

"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.

Randomized feasibility study of suction-tube uterine tamponade for postpartum hemorrhage.

OBJECTIVE: To identify an inexpensive catheter suitable for uterine suction tamponade (UST) for postpartum hemorrhage and assess its functionality. METHODS: Randomized, single-center, double-blind feasibility study in East London, South Africa, among 45 women undergoing cesarean delivery between October and November 2018. A search of medical supply websites for catheters with predefined characteristics (inexpensive, flexible, wide-bore, circumferentially-arranged side apertures, rounded tip) identified the FG36 Levin stomach tube. During cesarean, the tube was placed in the uterus and connected transvaginally to a suction unit. Participants were randomized via a computer-generated random sequence to early (after uterine closure; n=24) or delayed (after skin closure; n=21) UST. RESULTS: The tube functioned well with respect to stability in the uterus and aspirating blood from the uterine cavity without blockage. Blood loss was similar between the groups (mean difference, 7.3 mL; 95% confidence interval, -61 to 75; P=0.433), as were secondary outcomes. There were no complications. Absolute effectiveness was not tested because there was no non-suction group. CONCLUSION: The FG36 Levin tube was found to be a suitable device for "suction-tube uterine tamponade". There was no difference in functionality between early and late UST. Future trials should assess the effectiveness of this approach for postpartum hemorrhage. CLINICAL TRIAL REGISTRATION: Registered in the Pan African Clinical Trial Registry as PACTR201809584199573.