NCT03626844

Maternal Outcomes Following Manual Lysis of the Placenta.

Maternal Outcomes Following Manual Lysis of the Placenta After Fifteen Compared to Thirty Minutes. A Randomized Controlled Trial.

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: HaEmek Medical Center, Israel · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Comparison of maternal outcomes following manual lysis of placenta 15 vs 30 minutes after delivery. A primary outcome of the drop in hemoglobin will be compared between the two groups. Secondary outcomes include maternal satisfaction, time to first breastfeeding, length of hospital stay, infection rate etc.

Detailed description

Women undergoing spontaneous term vaginal delivery with epidural analgesia will be randomly assigned into one of two groups: 1. manual lysis of placenta 15 minutes after delivery. 2. waiting 30 minutes and then manual lysis of placenta. Both groups will be managed actively during the 3rd stage of delivery, including oxytocin administration and controlled cord traction. Women who develop active bleeding will be promptly treated with manual lysis and excluded from the study. Manual lysis will be performed under epidural analgesia, and prophylactic antibiotics will be administered. Primary outcome of comparison between the two groups: hemoglobin drop after delivery. Secondary outcomes include: maternal satisfaction, time to first breastfeeding, length of hospital stay, infection rate etc.

Conditions

• Third Stage of Delivery

Interventions

Type	Name	Description
PROCEDURE	Manual Lysis of Placenta after 15 minutes (Intervention)	Manual Lysis of Placenta after 15 minutes: We administer prophylactic antibiotics, under epidural analgesia, under aseptic conditions, we perform manual lysis of placenta by introducing the hand through the vagina to the uterine cavity, separating and removing the placenta.
PROCEDURE	Manual Lysis of Placenta after 30 minutes (Control)	Manual Lysis of Placenta after 30 minutes: We administer prophylactic antibiotics, under epidural analgesia, under aseptic conditions, we perform manual lysis of placenta by introducing the hand through the vagina to the uterine cavity, separating and removing the placenta.

Timeline

• Start date: 2018-11-20
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2018-08-13
• Last updated: 2020-02-13

Locations

1 site across 1 country: Israel