Postpartum HaemorrhageNCT02136719
Bimanual Uterine Compression to Reduce Blood Loss and Prevent Postpartum Haemorrhage After Vaginal Delivery
A study testing bimanual uterine compression in people with Postpartum Haemorrhage, run by Benha University at 1 site in Egypt.
Trial summary
the investigators aim to compare bimanual uterine compression immediately after delivery of the placenta for 5 minutes versus no intervention for the prevention of postpartum hemorrhage in Women at high risk for primary atonic postpartum hemorrhage. Read more about this study
- Who is it for?
- Ages 19 to 49 years, women only
- Conditions the study is for
- Postpartum Haemorrhage
- What is being tested?
- bimanual uterine compression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2014to Dec 2020
- 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 19 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Gestational age more than 28 weeks the gestational age was determined based upon the date of the first day of last normal menstrual period and confirmed by ultrasound scan during the 1st trimester
- Women at high risk for primary atonic postpartum hemorrhage
- Over distended uterus
- Large fetus
- Multiple fetuses
- Hydramnios
Show all 14Show fewer
- Distension with clots accidental hemorrhage
- Exhausted myometrium
- Prolonged labor
- Oxytocin or prostaglandin stimulation
- Chorioamnionitis
- Previous uterine atony
- Placenta previa
- Marked anemia
Who cannot join
- Cervical tear
- extensive birth canal tear
- Postpartum hemorrhage
- Retained placenta
- Coagulopathy
- Chronic medical illness hepatic renal
- Pregnancy induced hypertension PIH
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
khalid ibrahim, MD contact
ibrahim zweel contact
Egypt1 site, 1 recruiting
- Recruiting
Benha univesity hospital and afhsa
Banhā, El Qualyobia, 13518
khalid mohamed, 201281469651, dr.khalidkhader77@yahoo.com
ibrahim zweel, MD
About this study
the investigators aim to compare bimanual uterine compression immediately after delivery of the placenta for 5 minutes versus no intervention for the prevention of postpartum hemorrhage in Women at high risk for primary atonic postpartum hemorrhage. The primary outcome is postpartum haemorrhage (blood loss of ≥ 500 ml) while the Secondary outcomes include use of additional uterotonics and need for blood transfusion.
Read the detailed description
the investigators conduct a prospective non- randomized study at Department of Obstetrics and Gynecology, Benha University Hospital, since April 2014 till May 2016, after approval of the study protocol by the Local Ethical Committee. A written informed consent is obtained from eligible women before induction or at early stage of labour.
Women with singleton pregnancies of more than 28 weeks' gestation who are admitted to hospital and candidates for vaginal delivery are eligible for the study .Gestational age more than 28 weeks the gestational age is determined based upon the date of the first day of last normal menstrual period and confirmed by ultrasound scan during the 1st trimester.
The patients (520) are divided into two groups, Group A (260) receive bimanual uterine compression immediately after delivery of the placenta for 5 minutes while Group B (260) receive no intervention.
The third stage of labour was managed as usual by clamping and cutting of umbilical cord, waiting for signs of placental separation and delivering the placenta by controlled cord traction.
Duration of the 3rd stage of labour is calculated. Patients are kept in labor room under observation for a period of 1 h.
Measurement of blood loss by a clean plastic lined absorbent drape placed under the woman's buttocks to collect all the blood lost after delivery of the baby and drainage of the amniotic fluid. The drape is changed as many times as needed. The woman stays on the drape or asked to wear a pad over the next 60 minutes. In the case of severe haemorrhage, the investigators follow the usual guidelines for management of postpartum haemorrhage, and the supplemental treatment registered. All drapes and pads are weighed on an electronic scale and the known dry weight of the linen is subtracted. As 1 ml of blood weighs close to 1 g, the balance in grams is assumed to be the total blood loss in ml.
- Conditions
- Postpartum Haemorrhage
- Being tested
- bimanual uterine compression
- Keywords
- Uterine massage, vaginal birth, postpartum haemorrhage
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bimanual uterine compressionProcedure or surgery
bimanual uterine compression immediately after delivery of placenta for 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | bimanual uterine compression immediately after delivery of placenta for 5 minutes in 260 women Receives: Procedure: bimanual uterine compression |
| Group B | No intervention | no intervention (260 women). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss 500 ml or more after enrolment
estimating blood loss from vagina
Measured: 60 minutes after enrolment
Secondary outcomes (3)
Blood loss 1000 ml or more after enrolment
estimating blood loss by collecting it
Measured: (up to 30 and 60 minutes) after enrolment
Use of additional uterotonics or other procedures
giving drugs IV
Measured: 60 minutes
Blood transfusion
giving how many units of PRBCS
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HaemorrhageStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khalid abd aziz mohamed, Benha University
- Investigators
- ibrahim zweel, Principal investigator, Department of Obstetrics and Gynecology,AFHSA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136719
- Sponsor's protocol ID
- khalidkhader 2
- Status last verified
- Mar 2020
- First submitted
- 11 May 2014
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bimanual Uterine Compression to Reduce Blood Loss and Prevent Postpartum Haemorrhage After Vaginal Delivery
- ClinicalTrials.gov ID
- NCT02136719
- Acronym / sponsor ID
- khalidkhader 2
- Conditions
- Postpartum Haemorrhage
- Keywords
- Uterine massage, vaginal birth, postpartum haemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 13 May 2014 (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 investigators aim to compare bimanual uterine compression immediately after delivery of the placenta for 5 minutes versus no intervention for the prevention of postpartum hemorrhage in Women at high risk for primary atonic postpartum hemorrhage. The primary outcome is postpartum haemorrhage (blood loss of ≥ 500 ml) while the Secondary outcomes include use of additional uterotonics and need for blood transfusion.
Detailed description
the investigators conduct a prospective non- randomized study at Department of Obstetrics and Gynecology, Benha University Hospital, since April 2014 till May 2016, after approval of the study protocol by the Local Ethical Committee. A written informed consent is obtained from eligible women before induction or at early stage of labour.
Women with singleton pregnancies of more than 28 weeks' gestation who are admitted to hospital and candidates for vaginal delivery are eligible for the study .Gestational age more than 28 weeks the gestational age is determined based upon the date of the first day of last normal menstrual period and confirmed by ultrasound scan during the 1st trimester.
The patients (520) are divided into two groups, Group A (260) receive bimanual uterine compression immediately after delivery of the placenta for 5 minutes while Group B (260) receive no intervention.
The third stage of labour was managed as usual by clamping and cutting of umbilical cord, waiting for signs of placental separation and delivering the placenta by controlled cord traction.
Duration of the 3rd stage of labour is calculated. Patients are kept in labor room under observation for a period of 1 h.
Measurement of blood loss by a clean plastic lined absorbent drape placed under the woman's buttocks to collect all the blood lost after delivery of the baby and drainage of the amniotic fluid. The drape is changed as many times as needed. The woman stays on the drape or asked to wear a pad over the next 60 minutes. In the case of severe haemorrhage, the investigators follow the usual guidelines for management of postpartum haemorrhage, and the supplemental treatment registered. All drapes and pads are weighed on an electronic scale and the known dry weight of the linen is subtracted. As 1 ml of blood weighs close to 1 g, the balance in grams is assumed to be the total blood loss in ml.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: bimanual uterine compressionbimanual uterine compression immediately after delivery of placenta for 5 minutes in 260 women |
| Group B | No intervention | –no intervention (260 women). |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Gestational age more than 28 weeks the gestational age was determined based upon the date of the first day of last normal menstrual period and confirmed by ultrasound scan during the 1st trimester
- Women at high risk for primary atonic postpartum hemorrhage
Key exclusion criteria (8 listed)
- Cervical tear
- extensive birth canal tear
- Postpartum hemorrhage
- Retained placenta
- Coagulopathy
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 |
|---|---|---|
| bimanual uterine compressionbimanual uterine compression immediately after delivery of placenta for 5 minutes | Procedure or surgery | Group A |
Primary outcome
Blood loss 500 ml or more after enrolment
Time frame: 60 minutes after enrolment
estimating blood loss from vagina
3 secondary outcomes
Blood loss 1000 ml or more after enrolment
Time frame: (up to 30 and 60 minutes) after enrolment
Use of additional uterotonics or other procedures
Time frame: 60 minutes
Blood transfusion
Time frame: 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
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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.
khalid ibrahim, MD contact
ibrahim zweel contact
ibrahim zweel principal investigator
Department of Obstetrics and Gynecology,AFHSA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bimanual uterine compression in people with Postpartum Haemorrhage, run by Benha University at 1 site in Egypt.
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 14 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 10 Mar 2020. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact khalid ibrahim, MD (dr.khalidkhader77@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss 500 ml or more after enrolment (time frame: 60 minutes after enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2020.