Placental Removal Method And Uterine Massage On Preventing Postpartum Hemorrhage

NCT06192836 | Unknown DMC

• 1 other identifier: AEŞH-EK1-2023-562
• Study Type: observational
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Postpartum Atony; Uterine massage; Hemorrhage; Placenta; Cesarean

Outcome Measures

Primary Outcomes (3)

• Comparison of patients' preoperative and postoperative hemoglobin levels

  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

  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

  Postoperative 30th minute, 1st and 2nd hour shock indices (heart rate (beats per minute) / systolic blood pressure(mmHg) ) will be compared

  2 hours

Secondary Outcomes (2)

• Comparison of the patients' postoperative heart rate

  2 hours

• Comparison of the patients' postoperative systolic and diastolic blood pressure

  2 hours

Study Arms (6)

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

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

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

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

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

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

Interventions

Manual Removal 1 PROCEDURE

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

Group 1-

Manual Removal 2 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 2

Controlled Cord Traction 1 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 3

Controlled Cord Traction 2 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 4

Controlled Cord Traction+Uterine Massage 1 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 5

Controlled Cord Traction+Uterine Massage 2 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

Group 6

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Busra Lekesiz: lead

Related Publications (3)

• Anorlu RI, Maholwana B, Hofmeyr GJ. Methods of delivering the placenta at caesarean section. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD004737. doi: 10.1002/14651858.CD004737.pub2.

  PMID: 18646109 BACKGROUND

• Hofmeyr GJ, Abdel-Aleem H, Abdel-Aleem MA. Uterine massage for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2013 Jul 1;2013(7):CD006431. doi: 10.1002/14651858.CD006431.pub3.

  PMID: 23818022 BACKGROUND

• Saccone G, Caissutti C, Ciardulli A, Berghella V. Uterine massage for preventing postpartum hemorrhage at cesarean delivery: Which evidence? Eur J Obstet Gynecol Reprod Biol. 2018 Apr;223:64-67. doi: 10.1016/j.ejogrb.2018.02.023. Epub 2018 Feb 23.

  PMID: 29499526 BACKGROUND

MeSH Terms

Conditions

Postpartum Hemorrhage; Uterine Inertia; Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dystocia

Study Officials

• Busra Lekesiz

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

sumeyye sarıtas

CONTACT

+903122790000; etliksh.iletisim@saglik.gov.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Doctor

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: January 10, 2024
• Primary Completion: December 22, 2024
• Study Completion: February 22, 2025
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share