Placental Removal Method And Uterine Massage On Preventing Postpartum Hemorrhage

January 4, 2024 updated by: Busra Lekesiz

The Effect of Placental Removal Method and Uterine Massage at Cesarean Delivery on Preventing Postpartum Hemorrhage

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
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
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
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
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
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
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
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
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of patients' preoperative and postoperative hemoglobin levels
Time Frame: 24 hours
The basal hemoglobin levels ( gr/dL) of the patients will be compared with the hemoglobin levels at 2nd, 6th and 24th hours.
24 hours
Comparison of patients' preoperative and postoperative hematocrit levels
Time Frame: 24 hours
The basal hematocrit levels (%) of the patients will be compared with the hematocrit levels at 2nd, 6th and 24th hours
24 hours
Comparison of patients' postoperative shock indexes
Time Frame: 2 hours
Postoperative 30th minute, 1st and 2nd hour shock indices (heart rate (beats per minute) / systolic blood pressure(mmHg) ) will be compared
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the patients' postoperative heart rate
Time Frame: 2 hours
Patients postoperative 30th minute, 1st and 2nd hour heart rate (beats in minute) will be compared
2 hours
Comparison of the patients' postoperative systolic and diastolic blood pressure
Time Frame: 2 hours
Patients postoperative 30th minute, 1st and 2nd hour systolic and diastolic blood pressure (mmHg) will be compared
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Busra Lekesiz

Investigators

  • Principal Investigator: Busra Lekesiz, Ankara Etlik City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 10, 2024

Primary Completion (Estimated)

December 22, 2024

Study Completion (Estimated)

February 22, 2025

Study Registration Dates

First Submitted

December 21, 2023

First Submitted That Met QC Criteria

January 4, 2024

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEŞH-EK1-2023-562

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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