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Trial record 22 of 618 for:    Hemorrhage AND postpartum

Bimanual Uterine Compression to Reduce Blood Loss and Prevent Postpartum Haemorrhage After Vaginal Delivery

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ClinicalTrials.gov Identifier: NCT02136719
Recruitment Status : Recruiting
First Posted : May 13, 2014
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
khalid abd aziz mohamed, Benha University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Postpartum Haemorrhage Procedure: bimanual uterine compression Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Bimanual Uterine Compression to Reduce Blood Loss and Prevent Postpartum Haemorrhage After Vaginal Delivery
Study Start Date : April 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A
bimanual uterine compression immediately after delivery of placenta for 5 minutes in 260 women
Procedure: bimanual uterine compression
bimanual uterine compression immediately after delivery of placenta for 5 minutes

No Intervention: Group B
no intervention (260 women).



Primary Outcome Measures :
  1. Blood loss 500 ml or more after enrolment [ Time Frame: 60 minutes after enrolment ]
    estimating blood loss from vagina


Secondary Outcome Measures :
  1. Blood loss 1000 ml or more after enrolment [ Time Frame: (up to 30 and 60 minutes) after enrolment ]
    estimating blood loss by collecting it

  2. Use of additional uterotonics or other procedures [ Time Frame: 60 minutes ]
    giving drugs IV

  3. Blood transfusion [ Time Frame: 60 minutes ]
    giving how many units of PRBCS



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Women at high risk for primary atonic postpartum hemorrhage

    • Over distended uterus
    • Large fetus
    • Multiple fetuses
    • Hydramnios
    • Distension with clots accidental hemorrhage
    • Exhausted myometrium
    • Prolonged labor
    • Oxytocin or prostaglandin stimulation
    • Chorioamnionitis
    • Previous uterine atony
    • Placenta previa
    • Marked anemia

Exclusion Criteria:

  1. Cervical tear
  2. extensive birth canal tear
  3. Postpartum hemorrhage
  4. Retained placenta
  5. Coagulopathy
  6. Chronic medical illness hepatic renal
  7. Pregnancy induced hypertension PIH
  8. Refusal to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02136719


Contacts
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Contact: khalid ibrahim, MD dr.khalidkhader77@yahoo.com
Contact: ibrahim zweel dribrahimzweel@gmail.com

Locations
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Egypt
Benha univesity hospital and afhsa Recruiting
Banhā, El Qualyobia, Egypt, 13518
Contact: khalid mohamed    201281469651    dr.khalidkhader77@yahoo.com   
Principal Investigator: ibrahim zweel, MD         
Sponsors and Collaborators
Benha University
Investigators
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Principal Investigator: ibrahim zweel Department of Obstetrics and Gynecology,AFHSA

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Responsible Party: khalid abd aziz mohamed, lecturer of ob/gyn, Benha University
ClinicalTrials.gov Identifier: NCT02136719     History of Changes
Other Study ID Numbers: khalidkhader 2
First Posted: May 13, 2014    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019

Keywords provided by khalid abd aziz mohamed, Benha University:
Uterine massage
vaginal birth
postpartum haemorrhage

Additional relevant MeSH terms:
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Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage