Clinical trial NCT06192836: Placental Removal Method And Uterine Massage On Preventing Postpartum Hemorrhage
Official title: The Effect of Placental Removal Method and Uterine Massage at Cesarean Delivery on Preventing Postpartum Hemorrhage
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Postpartum Hemorrhage
Cesarean Section Complications
Uterine Atony
Keywords: Postpartum Atony
Uterine massage
Hemorrhage
Placenta
Cesarean
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-01-05
Enrollment: 360
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of patients' preoperative and postoperative hemoglobin levels
timeFrame: 24 hours
measure: Comparison of patients' preoperative and postoperative hematocrit levels
timeFrame: 24 hours
measure: Comparison of patients' postoperative shock indexes
timeFrame: 2 hours
Secondary outcomes:
measure: Comparison of the patients' postoperative heart rate
timeFrame: 2 hours
measure: Comparison of the patients' postoperative systolic and diastolic blood pressure
timeFrame: 2 hours
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Etlik City Hospital
name: Busra Lekesiz
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.