NCT02396771

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
445

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

2.8 years

First QC Date

March 19, 2015

Last Update Submit

July 20, 2021

Conditions

Postpartum Hemorrhage

Keywords

UterineMassageCompression

Outcome Measures

Primary Outcomes (1)

  • Incidence of blood loss of 500 mL or more

    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.

    2 years

Secondary Outcomes (5)

  • Maternal pain

    2 years

  • Change in hemoglobin as a measure of blood loss

    2 years

  • Use of therapeutic uterotonics

    2 years

  • Use of balloon or surgical procedures for postpartum hemorrhage

    2 years

  • Need for blood transfusion and hospital stay

    2 years

Study Arms (2)

Massage

EXPERIMENTAL

Women allocated to the uterine massage group will be provided with 2 minutes of trans-abdominal uterine massage starting promptly after placental delivery.

Procedure: Uterine Massage

Compression

EXPERIMENTAL

Women allocated to the uterine compression group will be provided with 2 minutes of sustained trans-abdominal uterine compression starting promptly after placental delivery.

Procedure: Uterine Compression

Interventions

Uterine MassagePROCEDURE

The massage will be performed as follows: palpating the uterine fundus, manually stimulating the fundus and the whole body of the uterus using fingers and palms steadily and repetitively.

Massage
Uterine CompressionPROCEDURE

The sustained uterine compression will be performed as follows: placing one hand in the vagina and pushing against the body of the uterus while the other hand compresses the fundus from above through the abdominal wall.

Compression

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

Related Publications (1)

  • Ghulmiyyah LM, El-Husheimi A, Usta IM, Colon-Aponte C, Ghazeeri G, Hobeika E, Mirza FG, Tamim H, Hamadeh C, Nassar AH. Effect of Sustained Uterine Compression versus Uterine Massage on Blood Loss after Vaginal Delivery: A Randomized Controlled Trial. Am J Perinatol. 2023 Nov;40(15):1644-1650. doi: 10.1055/s-0041-1739409. Epub 2021 Nov 14.

    PMID: 34775581DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Labib M Ghulmiyyah, MD

    AUBMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 19, 2015

First Posted

March 24, 2015

Study Start

January 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

July 22, 2021

Record last verified: 2021-07

Locations

LE(1)