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

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.

Study Overview

• Status: Unknown
• Conditions: Postpartum Haemorrhage
• Intervention / Treatment: Procedure: bimanual uterine compression

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 Type: Interventional
• Enrollment (Anticipated): 520
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Qualyobia
    • Banhā, El Qualyobia, Egypt, 13518
      • Recruiting
      • Benha univesity hospital and afhsa
      • Principal Investigator: ibrahim zweel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss 500 ml or more after enrolment	estimating blood loss from vagina	60 minutes after enrolment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss 1000 ml or more after enrolment	estimating blood loss by collecting it	(up to 30 and 60 minutes) after enrolment
Use of additional uterotonics or other procedures	giving drugs IV	60 minutes
Blood transfusion	giving how many units of PRBCS	60 minutes

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Principal Investigator: ibrahim zweel, Department of Obstetrics and Gynecology,AFHSA

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: May 11, 2014
• First Submitted That Met QC Criteria: May 12, 2014
• First Posted (Estimate): May 13, 2014

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Uterine massage; vaginal birth; postpartum haemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: khalidkhader 2

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