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Obstetrical & Gynecological Survey:
doi: 10.1097/01.ogx.0000421445.04738.9c
Obstetrics: Management of Labor, Delivery, and the Puerperium

Active Management of the Third Stage of Labour With and Without Controlled Cord Traction: A Randomised, Controlled, Non-inferiority Trial

Gülmezoglu, A. Metin; Lumbiganon, Pisake; Landoulsi, Sihem; Widmer, Mariana; Abdel-Aleem, Hany; Festin, Mario; Carroli, Guillermo; Qureshi, Zahida; Souza, João Paulo; Bergel, Eduardo; Piaggio, Gilda; Goudar, Shivaprasad S.; Yeh, John; Armbruster, Deborah; Singata, Mandisa; Pelaez-Crisologo, Cristina; Althabe, Fernando; Sekweyama, Peter; Hofmeyr, Justus; Stanton, Mary-Ellen; Derman, Richard; Elbourne, Diana

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Abstract

A common prophylactic intervention used in the third stage of labor to reduce postpartum hemorrhage (PPH) can be labeled as active management. In the full management package used for active management, oxytocin is administered soon after delivery in combination with controlled cord traction. However, because the proper use of controlled cord traction requires manual skills, this procedure has been recommended only for skilled birth attendants. Unfortunately, a substantial proportion of maternal deaths from hemorrhage occur in settings in which skilled birth attendants are not available. Some evidence suggests that a simplified active package omitting controlled cord traction may have a similar effect on preventing blood loss, indicating that the uterotonic component in active management may be effective on its own. The contribution of controlled cord traction to blood loss is largely unknown.

This multicenter, noninferiority, randomized controlled trial investigated the effect of a simplified management package omitting controlled cord traction from active management on third-stage blood loss. The study was conducted between 2009 and 2010 in 16 hospitals and 2 primary health care centers in Argentina, Egypt, India, Kenya, the Philippines, South Africa, Thailand, and Uganda. Eligible women expecting planned singleton vaginal deliveries (not planned cesareans) were randomly assigned to placental delivery with the simplified package (with aid of gravity and maternal effort) or full package (controlled cord traction applied immediately after uterine contraction and cord clamping). Women were stratified by country. Intramuscular oxytocin 10 IU was administered in both groups immediately after birth with cord clamping after 1 to 3 minutes. Uterine massage was performed after placental delivery according to the local policy in each country. Blinding of investigators, participants, or assessors was not possible after randomization. The primary (noninferiority) outcome was severe PPH (blood loss of ≥1000 mL). The prestated noninferiority margin for the risk ratio was 1.3. Primary analysis was according to modified intention to treat, excluding women who had emergency caesarean deliveries.

For the final analysis, 11,861 women were randomly assigned to the simplified package and 11,820 to the full package group. The data showed that for the primary outcome of blood loss of 1000 mL or more, the risk ratio was 1.09 (95% confidence interval [CI], 0.91-1.31), and the upper 95% CI limit crossed the prestated noninferiority margin of 1.30. One case of uterine inversion was observed in the full package group; other adverse events were hemorrhage related.

These findings show that omission of controlled cord traction has little impact on the risk of severe hemorrhage. The data suggest that oxytocin can be used as the routine uterotonic for prevention of PPH in settings where a trained health care worker is not available.

© 2012 Lippincott Williams & Wilkins, Inc.

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