Maternal Outcomes Following Manual Lysis of the Placenta.

HaEmek Medical Center, Israel

Status: Suspended

Conditions: Third Stage of Delivery

Treatments: Procedure: Manual Lysis of Placenta after 15 minutes (Intervention); Procedure: Manual Lysis of Placenta after 30 minutes (Control)

Study type: Interventional

Funder types: Other

Identifiers

NCT03626844

0022-18EMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Term spontaneous vaginal delivery.
• Singleton Pregnancy.
• Epidural Analgesia during delivery.
• Age between 18 and 45 years.

Exclusion criteria

• Active bleeding after delivery that warrants prompt removal of placenta regardless of time from delivery.
• Vacuum Extraction.
• Intrapartum Infection.
• Intrapartum fever above 38 degrees celsius.
• Wide 3rd and 4th degree perineal tears that mandate suturing under general anaesthesia.
• Thalassemia Carriers.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Manual Lysis after 15 minutes (Intervention)

Experimental group

Description:

Manual Lysis of Placenta 15 minutes after Delivery.

Treatment:

Procedure: Manual Lysis of Placenta after 15 minutes (Intervention)

Manual lysis after 30 minutes (Control)

Active Comparator group

Description:

Waiting 30 minutes after delivery and then manual lysis of the placenta.

Treatment:

Procedure: Manual Lysis of Placenta after 30 minutes (Control)