Placental Removal Method And Uterine Massage On Preventing Postpartum Hemorrhage

Busra Lekesiz

Status: Not yet enrolling

Conditions: Cesarean Section Complications; Uterine Atony; Postpartum Hemorrhage

Treatments: Procedure: Controlled Cord Traction 2; Procedure: Controlled Cord Traction 1; Procedure: Controlled Cord Traction+Uterine Massage 1; Procedure: Manual Removal 2; Procedure: Controlled Cord Traction+Uterine Massage 2; Procedure: Manual Removal 1

Study type: Observational

Funder types: Other

Identifiers

NCT06192836

AEŞH-EK1-2023-562

Details and patient eligibility

About

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)

Full description

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.

Enrollment: 360 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• In utero fetal death
• Multiple gestation
• History of uterine atony
• Vaginal birth
• Previous history of cesarean delivery

Trial design

360 participants in 6 patient groups

Group 1-

Description:

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

Treatment:

Procedure: Manual Removal 1

Group 2

Description:

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

Treatment:

Procedure: Manual Removal 2

Group 3

Description:

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

Treatment:

Procedure: Controlled Cord Traction 1

Group 4

Description:

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

Treatment:

Procedure: Controlled Cord Traction 2

Group 5

Description:

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

Treatment:

Procedure: Controlled Cord Traction+Uterine Massage 1

Group 6

Description:

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

Treatment:

Procedure: Controlled Cord Traction+Uterine Massage 2