Maternal Outcomes Following Manual Lysis of the Placenta.
- Conditions
- Third Stage of Delivery
- 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- Female
- Target Recruitment
- 100
- Term spontaneous vaginal delivery.
- Singleton Pregnancy.
- Epidural Analgesia during delivery.
- Age between 18 and 45 years.
- 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
- 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 Febrile morbidity within one week of delivery Rate of developing fever after delivery
Rate of Blood Products Given 7 days Number and type of blood products given peripartum
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
Related Research Topics
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Trial Locations
- Locations (1)
Haemek Medical Center
🇮🇱Afula, Israel
Haemek Medical Center🇮🇱Afula, Israel