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

July 20, 2021 updated by: Dr. Labib Ghulmiyyah, American University of Beirut Medical Center

Effect of Uterine Massage Versus Sustained Uterine Compression on Blood Loss and Maternal Pain After Vaginal Delivery: a Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
445

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
      • Beirut, Lebanon
        • American University of Beirut Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Massage
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
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.
Experimental: 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.
Procedure: Uterine Compression
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of blood loss of 500 mL or more
Time Frame: 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.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal pain
Time Frame: 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.
2 years
Change in hemoglobin as a measure of blood loss
Time Frame: 2 years
The change in hemoglobin will be defined as the mean difference of pre-delivery hemoglobin versus post-delivery hemoglobin in each group.
2 years
Use of therapeutic uterotonics
Time Frame: 2 years
the need to use uterotonic agent for PPH such a misoprostol or ergotamines
2 years
Use of balloon or surgical procedures for postpartum hemorrhage
Time Frame: 2 years
needingto insert tamponading devices such as balloon
2 years
Need for blood transfusion and hospital stay
Time Frame: 2 years
needing to transfuse the patient due to severe anemia
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
American University of Beirut Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Labib M Ghulmiyyah, MD, AUBMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OGY.LG.02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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