"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.