Placental Removal Method And Uterine Massage On Preventing Postpartum Hemorrhage

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06192836
• Other study ID #: AESH-EK1-2023-562
• Status: Not yet recruiting
• Start date: January 10, 2024
• Est. completion date: February 22, 2025

Study information

• Verified date: January 2024
• Source: Ankara Etlik City Hospital
• Contact: sumeyye saritas
• Phone: +903122790000
• Email: etliksh.iletisim[@]saglik.gov.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: February 22, 2025
• Est. primary completion date: December 22, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Hemorrhage
• Postpartum Hemorrhage
• Uterine Atony
• Uterine Inertia

Intervention

Procedure:
• Manual Removal 1
Placenta will be removed manually Uterine incision will be repaired as double layered No uterine massage will be performed
• Manual Removal 2
Placenta will be removed manually Uterine incision will be repaired as double layered Uterine massage will be performed for one minute duration, after uterine incision is closed
• Controlled Cord Traction 1
Placenta will be delivered via controlled cord traction Uterine incision will be repaired as double layered No uterine massage will be performed
• Controlled Cord Traction 2
Placenta will be delivered via controlled cord traction Uterine incision will be repaired as double layered Uterine massage will be performed for one minute duration, after uterine incision is closed
• Controlled Cord Traction+Uterine Massage 1
Placenta will be delivered via controlled cord traction plus uterine massage Uterine incision will be repaired as double layered No uterine massage will be performed after placental delivery
• Controlled Cord Traction+Uterine Massage 2
Placenta will be delivered via controlled cord traction plus uterine massage Uterine incision will be repaired as double layered Additional uterine massage for one minute duration will be performed after uterine incision is closed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Busra Lekesiz

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Comparison of the patients' postoperative heart rate	Patients postoperative 30th minute, 1st and 2nd hour heart rate (beats in minute) will be compared	2 hours
Secondary	Comparison of the patients' postoperative systolic and diastolic blood pressure	Patients postoperative 30th minute, 1st and 2nd hour systolic and diastolic blood pressure (mmHg) will be compared	2 hours