Maternal Outcomes Following Manual Lysis of the Placenta.

Not Applicable

Suspended

• Conditions: Third Stage of Delivery
• Interventions: Procedure: Manual Lysis of Placenta after 15 minutes (Intervention); Procedure: Manual Lysis of Placenta after 30 minutes (Control)

• Registration Number: NCT03626844
• Lead Sponsor: HaEmek Medical Center, Israel

Brief 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.

Study Timeline

• Study First Submitted: 2018-08-08
• Study First Submitted QC: 2018-08-08
• Study First Posted: 2018-08-13
• Study Start: 2018-11-20
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-13
• Primary Completion: 2020-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual Lysis after 15 minutes (Intervention)	Manual Lysis of Placenta after 15 minutes (Intervention)	Manual Lysis of Placenta 15 minutes after Delivery.
Manual lysis after 30 minutes (Control)	Manual Lysis of Placenta after 30 minutes (Control)	Waiting 30 minutes after delivery and then manual lysis of the placenta.

Primary Outcome Measures

Name	Time	Method
Hemoglobin Drop	within 24 hours after delivery	The difference between Hemoglobin levels before and after delivery

Secondary Outcome Measures

Name	Time	Method
Rate of Blood Products Given	7 days	Number and type of blood products given peripartum
Febrile morbidity	within one week of delivery	Rate of developing fever after delivery
Blood Loss	7 days	Calculation of estimated blood loss during delivery by accepted formulas
First Nursing	7 days	Time until first breastfeeding
Hospital Stay	7 days	Length of Hospital stay in days
Maternal Satisfaction	7 days	Level of maternal satisfaction from the delivery process and interventions as evaluated by a numerical scale from 1 to 5 with 5 being highly satisfied

Trial Locations

Locations (1)

Haemek Medical Center; 🇮🇱 Afula, Israel