Postpartum HemorrhageNCT02396771
Effect of Uterine Massage Versus Sustained Uterine Compression on Blood Loss After Vaginal Delivery
A study testing Uterine Massage and Uterine Compression in people with Postpartum Hemorrhage, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Uterine Massage and Uterine Compression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 445 participants
- Where
- 1 siteLebanon
- Study dates
- Jan 2015to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Uterine Massage, Uterine Compression
- Keywords
- Uterine, Massage, Compression
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine MassageProcedure or surgery
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.
Uterine CompressionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Uterine Compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (5)
Maternal pain
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.
Measured: 2 years
Change in hemoglobin as a measure of blood loss
The change in hemoglobin will be defined as the mean difference of pre-delivery hemoglobin versus post-delivery hemoglobin in each group.
Measured: 2 years
Use of therapeutic uterotonics
the need to use uterotonic agent for PPH such a misoprostol or ergotamines
Measured: 2 years
Use of balloon or surgical procedures for postpartum hemorrhage
needingto insert tamponading devices such as balloon
Measured: 2 years
Need for blood transfusion and hospital stay
needing to transfuse the patient due to severe anemia
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 445 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Labib Ghulmiyyah, American University of Beirut Medical Center
- Investigators
- Labib M Ghulmiyyah, MD, Principal investigator, AUBMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396771
- Sponsor's protocol ID
- OGY.LG.02
- Status last verified
- Jul 2021
- First submitted
- 19 Mar 2015
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34775581
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Uterine Massage Versus Sustained Uterine Compression on Blood Loss and Maternal Pain After Vaginal Delivery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02396771
- Acronym / sponsor ID
- OGY.LG.02
- Conditions
- Postpartum Hemorrhage
- Keywords
- Uterine, Massage, Compression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 445 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massage | Experimental | Procedure: Uterine MassageWomen allocated to the uterine massage group will be provided with 2 minutes of trans-abdominal uterine massage starting promptly after placental delivery. |
| Compression | Experimental | Procedure: Uterine CompressionWomen allocated to the uterine compression group will be provided with 2 minutes of sustained trans-abdominal uterine compression starting promptly after placental delivery. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uterine MassageThe 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. | Procedure or surgery | Massage |
| Uterine CompressionThe 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. | Procedure or surgery | Compression |
Primary outcome
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.
5 secondary outcomes
Maternal pain
Time frame: 2 years
Change in hemoglobin as a measure of blood loss
Time frame: 2 years
Use of therapeutic uterotonics
Time frame: 2 years
Use of balloon or surgical procedures for postpartum hemorrhage
Time frame: 2 years
Need for blood transfusion and hospital stay
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Derived from this study: PubMed 34775581Ghulmiyyah 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.
Related trials for Postpartum Hemorrhage
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Labib M Ghulmiyyah, MD principal investigator
AUBMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uterine Massage and Uterine Compression in people with Postpartum Hemorrhage, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of blood loss of 500 mL or more (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02396771, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.