Maternal Outcomes Following Manual Lysis of the Placenta.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Third Stage of Delivery

Intervention / Treatment
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* Procedure: Manual Lysis of Placenta after 15 minutes (Intervention)
* Procedure: Manual Lysis of Placenta after 30 minutes (Control)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual Lysis after 15 minutes (Intervention)<br>Manual Lysis of Placenta 15 minutes after Delivery. | Procedure: Manual Lysis of Placenta after 15 minutes (Intervention)<br>* 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.<br>* Other names: Manual Lysis of Placenta after 15 minutes;|
| Active Comparator: Manual lysis after 30 minutes (Control)<br>Waiting 30 minutes after delivery and then manual lysis of the placenta. | Procedure: Manual Lysis of Placenta after 30 minutes (Control)<br>* 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.<br>* Other names: Manual Lysis of Placenta after 30 minutes;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin Drop | The difference between Hemoglobin levels before and after delivery | within 24 hours after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Blood Products Given | Number and type of blood products given peripartum | 7 days | 
| Blood Loss | Calculation of estimated blood loss during delivery by accepted formulas | 7 days | 
| Febrile morbidity | Rate of developing fever after delivery | within one week of delivery | 
| First Nursing | Time until first breastfeeding | 7 days | 
| Hospital Stay | Length of Hospital stay in days | 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 | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Manual Lysis, Postpartum Hemorrhage, Third Stage of Delivery.