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NCT Number: NCT06192836

Placental Removal Method And Uterine Massage 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)

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Key information

Conditions

Postpartum Hemorrhage Cesarean Section Complications Dystocia Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Atony Uterine Hemorrhage Uterine Inertia

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual Removal 1

Procedure
  • Placenta will be removed manually
  • Uterine incision will be repaired as double layered
  • No uterine massage will be performed

Manual Removal 2

Procedure
  • 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

Procedure
  • 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

Procedure
  • 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

Procedure
  • 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

Procedure
  • 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

Primary outcomes

  1. 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.

  2. 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

  3. 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

Secondary outcomes

  1. 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. 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

Sponsors and collaborators

Lead sponsor

Busra Lekesiz

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2024
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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