Third Stage of Delivery
Conditions
Keywords
Manual Lysis, Postpartum Hemorrhage, Third Stage.
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 blood transfusion rate, maternal satisfaction, time to first breastfeeding, length of hospital stay, infection rate etc.
Detailed description
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.
Interventions
PROCEDUREManual Lysis of Placenta after 15 minutes (Intervention)
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.
PROCEDUREManual Lysis of Placenta after 30 minutes (Control)
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.
Sponsors
Holy Family Hospital, Nazareth, Israel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Drop | within 24 hours after delivery | The difference between Hemoglobin levels before and after delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Febrile morbidity | within one week of delivery | Rate of developing fever after delivery |
| 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 |
| Hemoglobin Drop | up to 6 weeks postpartum | The difference between Hemoglobin levels before and after delivery |
Countries
Israel
Contacts
CONTACTMais Abu Nofal, M.D.
CONTACTRaed Salim, M.D.
STUDY_CHAIRRaed Salim, M.D.
Holy Family Hospital, Nazareth, Israel
Outcome results
None listed