Effect of Uterine Massage Versus Sustained Uterine Compression on Blood Loss After Vaginal Delivery

Not Applicable

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Procedure: Uterine Massage; Procedure: Uterine Compression

• Registration Number: NCT02396771
• Lead Sponsor: American University of Beirut Medical Center

Brief Summary

The purpose of this study is to compare trans-abdominal uterine massage to sustained uterine compression after vaginal delivery with respect to blood loss and maternal pain. It is a randomized controlled trial that will be conducted at the American University of Beirut Medical Center - Delivery Suite.

Detailed Description

Women allocated to either the massage or compression group will be given 10 units of oxytocin intramuscularly immediately after delivery of the shoulder and controlled cord traction will be performed to assist placental delivery. The umbilical cord will be clamped and cut approximately 1 minute after delivery of the baby. The uterine fundus will be rubbed and blood clots expelled as quickly as possible after delivery of the placenta.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-03-19
• Study First Submitted QC: 2015-03-23
• Study First Posted: 2015-03-24
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 445

Inclusion Criteria

• Women giving birth vaginally, aged between 20 and 40 years, with a singleton pregnancy, gestational age of 36 or more weeks, and with fewer than or equal to three previous childbirths.

Exclusion Criteria

• Exclusion criteria include multiple gestation, fetal malpresentation, the third stage of labor lasting more than 30 minutes, a previous cesarean delivery, chorioamnionitis, three or more previous induced abortions, preeclampsia, fetal death, polyhydramnios, hemoglobin of 9 g/L or less before delivery, coagulopathy, on magnesium sulfate infusion, abruptio placentae and having an abdominal wall too thick to palpate the fundus of the uterus or to perform uterine massage or compressions after delivery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Massage	Uterine Massage	Women allocated to the uterine massage group will be provided with 2 minutes of trans-abdominal uterine massage starting promptly after placental delivery.
Compression	Uterine Compression	Women allocated to the uterine compression group will be provided with 2 minutes of sustained trans-abdominal uterine compression starting promptly after placental delivery.

Primary Outcome Measures

Name	Time	Method
Incidence of blood loss of 500 mL or more	2 years	Collection of lost blood will be initiated immediately after delivery of the neonate by putting a drape under the woman's buttocks. Blood collected will be weighed on an electronic scale together with the drape, and the amount will be recorded in grams after subtracting the weight of the drape. The amount of blood loss will be recorded 30 mins after delivery of the neonate. The amount of lost blood in grams will be converted to volume by dividing by 1.06 (blood density in g/mL) for the analysis.

Secondary Outcome Measures

Name	Time	Method
Maternal pain	2 years	Maternal discomfort and pain intensity will be evaluated after the intervention using a visual analogue scale (VAS), which consists of a two-sided rule with a 10 cm vertical or horizontal line linking two points, at one extreme indicating a total absence of pain and at the other the worst pain imaginable. The women will be required to mark a spot on the line corresponding to the intensity of their pain at that particular time on a possible scale of 0 to 10.
Change in hemoglobin as a measure of blood loss	2 years	The change in hemoglobin will be defined as the mean difference of pre-delivery hemoglobin versus post-delivery hemoglobin in each group.
Use of therapeutic uterotonics	2 years	the need to use uterotonic agent for PPH such a misoprostol or ergotamines
Use of balloon or surgical procedures for postpartum hemorrhage	2 years	needingto insert tamponading devices such as balloon
Need for blood transfusion and hospital stay	2 years	needing to transfuse the patient due to severe anemia

Trial Locations

Locations (1)

American University of Beirut Medical Center; 🇱🇧 Beirut, Lebanon