Placental Removal Method And Uterine Massage On Preventing Postpartum Hemorrhage
NCT06192836 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 360
Last updated 2024-01-05
Summary
Postpartum hemorrhage is the leading cause of maternal deaths in all over the world, especially in developing and underdeveloped countries. Medical and surgical methods exist for management of bleeding.
There are two surgical techniques for removal of the placenta on cesarean delivery, which are called manual removal and controlled cord traction. In manual removal group, the duration of surgery time might be shorter theoretically. Nevertheless, there are studies showing that manual removal of the placenta may increase postpartum endometritis and postpartum hemorrhage. The optimal method for removal of the placenta during the cesarean delivery remains uncertain (1).
It is a known fact that uterine massage after vaginal birth lowers the risk of postpartum hemorrhage (2) However, there is no study on how effective uterine massage is during cesarean delivery. In 2018, Saccone and colleagues wanted to publish a meta-analysis on the role of uterine massage in reducing postpartum bleeding during cesarean delivery, but when they examined the literature on the subject, they could not find a study which included only the group that gave birth by cesarean section and was free from bias. In the same publication, it was mentioned that it was necessary to investigate the effectiveness of uterine massage, which is a cost-free method that can reduce maternal morbidity in underdeveloped countries where maternal deaths due to postpartum bleeding are high, in cesarean section. (3)
Conditions
- Postpartum Hemorrhage
- Cesarean Section Complications
- Uterine Atony
Interventions
- PROCEDURE
-
Manual Removal 1
1. Placenta will be removed manually 2. Uterine incision will be repaired as double layered 3. No uterine massage will be performed
- PROCEDURE
-
Manual Removal 2
1. Placenta will be removed manually 2. Uterine incision will be repaired as double layered 3. Uterine massage will be performed for one minute duration, after uterine incision is closed
- PROCEDURE
-
Controlled Cord Traction 1
1. Placenta will be delivered via controlled cord traction 2. Uterine incision will be repaired as double layered 3. No uterine massage will be performed
- PROCEDURE
-
Controlled Cord Traction 2
1. Placenta will be delivered via controlled cord traction 2. Uterine incision will be repaired as double layered 3. Uterine massage will be performed for one minute duration, after uterine incision is closed
- PROCEDURE
-
Controlled Cord Traction+Uterine Massage 1
1. Placenta will be delivered via controlled cord traction plus uterine massage 2. Uterine incision will be repaired as double layered 3. No uterine massage will be performed after placental delivery
- PROCEDURE
-
Controlled Cord Traction+Uterine Massage 2
1. Placenta will be delivered via controlled cord traction plus uterine massage 2. Uterine incision will be repaired as double layered 3. Additional uterine massage for one minute duration will be performed after uterine incision is closed
Sponsors & Collaborators
-
Busra Lekesiz
lead OTHER_GOV
Principal Investigators
-
Busra Lekesiz · Ankara Etlik City Hospital
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-10
- Primary Completion
- 2024-12-22
- Completion
- 2025-02-22
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