Placental Removal Method And Uterine Massage On Preventing Postpartum Hemorrhage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-10

Study Completion Date

2025-02-22

Brief Summary

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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)

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Detailed Description

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In this study, data of patients who underwent emergency cesarean delivery in the Department of Obstetrics and Gynecology, Ankara Etlik City Hospital, will be collected

The parameters to be examined in the research are as follows:

1. Patients' postoperative 30th minute, 1st and 2nd hour systolic blood pressure, diastolic blood pressure, pulse rate, shock indexes
2. Volume of diuresis at postoperative first six hours
3. Hemoglobin and hematocrit values at preoperatively and 2nd, 6th, 24th hours postoperatively.
4. Duration of the surgery.
5. Need for additional dose of uterotonics
6. Need for surgical methods to manage postpartum bleeding
7. Duration of hospital stay

The sample size of this study was calculated with the Gpower3.1 computer program.

The total number of samples with 90% power and 95% confidence interval was calculated as 338 patients. The number of volunteers to participate in our study is planned to be 360 in total, 60 volunteers for each group, across 6 groups. Results will be considered statistically significant for p\< 0,05.

Conditions

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Postpartum Hemorrhage Cesarean Section Complications Uterine Atony

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1-

Operation will be performed by Dr BL

1. Patients' postoperative 30th minute, 1st and 2nd hour systolic blood pressure, diastolic blood pressure, pulse rate, shock indexes
2. Volume of diuresis at postoperative first six hours
3. Hemoglobin and hematocrit values at preoperatively and 2nd, 6th, 24th hours postoperatively.
4. Duration of the surgery.
5. Need for additional dose of uterotonics
6. Need for surgical methods to manage postpartum bleeding
7. Duration of hospital stay

Manual Removal 1

Intervention Type PROCEDURE

1. Placenta will be removed manually
2. Uterine incision will be repaired as double layered
3. No uterine massage will be performed

Group 2

Operation will be performed by Dr AC

1. Patients' postoperative 30th minute, 1st and 2nd hour systolic blood pressure, diastolic blood pressure, pulse rate, shock indexes
2. Volume of diuresis at postoperative first six hours
3. Hemoglobin and hematocrit values at preoperatively and 2nd, 6th, 24th hours postoperatively.
4. Duration of the surgery.
5. Need for additional dose of uterotonics
6. Need for surgical methods to manage postpartum bleeding
7. Duration of hospital stay

Manual Removal 2

Intervention Type PROCEDURE

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

Group 3

Operation will be performed by Dr SM

1. Patients' postoperative 30th minute, 1st and 2nd hour systolic blood pressure, diastolic blood pressure, pulse rate, shock indexes
2. Volume of diuresis at postoperative first six hours
3. Hemoglobin and hematocrit values at preoperatively and 2nd, 6th, 24th hours postoperatively.
4. Duration of the surgery.
5. Need for additional dose of uterotonics
6. Need for surgical methods to manage postpartum bleeding
7. Duration of hospital stay

Controlled Cord Traction 1

Intervention Type PROCEDURE

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

Group 4

Operation will be performed by Dr AS

1. Patients' postoperative 30th minute, 1st and 2nd hour systolic blood pressure, diastolic blood pressure, pulse rate, shock indexes
2. Volume of diuresis at postoperative first six hours
3. Hemoglobin and hematocrit values at preoperatively and 2nd, 6th, 24th hours postoperatively.
4. Duration of the surgery.
5. Need for additional dose of uterotonics
6. Need for surgical methods to manage postpartum bleeding
7. Duration of hospital stay

Controlled Cord Traction 2

Intervention Type PROCEDURE

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

Group 5

Operation will be performed by Dr EDD

1. Patients' postoperative 30th minute, 1st and 2nd hour systolic blood pressure, diastolic blood pressure, pulse rate, shock indexes
2. Volume of diuresis at postoperative first six hours
3. Hemoglobin and hematocrit values at preoperatively and 2nd, 6th, 24th hours postoperatively.
4. Duration of the surgery.
5. Need for additional dose of uterotonics
6. Need for surgical methods to manage postpartum bleeding
7. Duration of hospital stay

Controlled Cord Traction+Uterine Massage 1

Intervention Type PROCEDURE

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

Group 6

Operation will be performed by Dr SKE

1. Patients' postoperative 30th minute, 1st and 2nd hour systolic blood pressure, diastolic blood pressure, pulse rate, shock indexes
2. Volume of diuresis at postoperative first six hours
3. Hemoglobin and hematocrit values at preoperatively and 2nd, 6th, 24th hours postoperatively.
4. Duration of the surgery.
5. Need for additional dose of uterotonics
6. Need for surgical methods to manage postpartum bleeding
7. Duration of hospital stay

Controlled Cord Traction+Uterine Massage 2

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Live singleton pregnancy of 37 0/7 weeks or more
* Without history of previous uterine atony
* No comorbidities
* No gestational hypertension or gestational diabetes mellitus