An interventional study of Manual Lysis of Placenta after 15 minutes (Intervention) and Manual Lysis of Placenta after 30 minutes (Control) in Third Stage of Delivery, sponsored by Holy Family Hospital, Nazareth, Israel. Recruiting at 1 site in Israel. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Holy Family Hospital, Nazareth, Israel · Not applicable, Interventional, and Prevention
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 blood transfusion rate, maternal satisfaction, time to first breastfeeding, length of hospital stay, infection rate etc.
Women undergoing spontaneous vaginal delivery at term with epidural analgesia will be randomly assigned to one of two groups: (1) manual removal of the placenta 15 minutes after delivery or (2) expectant management for 30 minutes, followed by manual removal of the placenta if it has not been delivered.
Both groups will receive active management of the third stage of labor, including oxytocin administration. Participants who develop active bleeding will undergo immediate manual removal of the placenta according to standard clinical care. Manual removal will be performed under epidural analgesia, and prophylactic antibiotics will be administered.
The primary outcome will be the difference in postpartum hemoglobin reduction between the two groups. Secondary outcomes will include incidence of blood transfusion, maternal satisfaction, time to first breastfeeding, length of hospital stay, infection rate.
469 studies on the registry are indexed under Postpartum Hemorrhage; 76 are open to participants now.
This study's planned enrollment of 100 is below the median of 148 across 360 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →Holy Family Hospital, Nazareth, Israel is the lead sponsor of 10 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Manual Lysis of Placenta 15 minutes after Delivery.
Procedure: Manual Lysis of Placenta after 15 minutes (Intervention)
Waiting 30 minutes after delivery and then manual lysis of the placenta.
Procedure: Manual Lysis of Placenta after 30 minutes (Control)
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.
Also known as: Manual Lysis of Placenta after 15 minutes
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.
Also known as: Manual Lysis of Placenta after 30 minutes
Hemoglobin Drop
The difference between Hemoglobin levels before and after delivery
Time frame: within 24 hours after delivery
Rate of Blood Products Given
Number and type of blood products given peripartum
Time frame: 7 days
Blood Loss
Calculation of estimated blood loss during delivery by accepted formulas
Time frame: 7 days
Febrile morbidity
Rate of developing fever after delivery
Time frame: within one week of delivery
First Nursing
Time until first breastfeeding
Time frame: 7 days
Hospital Stay
Length of Hospital stay in days
Time frame: 7 days
Maternal Satisfaction
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
Time frame: 7 days
Hemoglobin Drop
The difference between Hemoglobin levels before and after delivery
Time frame: up to 6 weeks postpartum
Plan to share: Yes — All IPD that underlie results in a publication
Supporting information: Study protocol, Clinical study report
Time frame: After publication (starting 6 months after publication).
Access criteria: De-identified IPD will be available to academic or clinical researchers for meta-analyses, and research addressing questions related to the study topic. Requests must include a research protocol, statistical analysis plan, ethics approval, and details of the research team. Requests will be reviewed by the principal investigator. Data will be provided after approval and completion of a data-sharing agreement.
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Holy Family Hospital, Nazareth, Israel