Clinical trial NCT02136719: Bimanual Uterine Compression to Reduce Blood Loss and Prevent Postpartum Haemorrhage After Vaginal Delivery
Official title: Bimanual Uterine Compression to Reduce Blood Loss and Prevent Postpartum Haemorrhage After Vaginal Delivery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postpartum Haemorrhage
Keywords: Uterine massage
vaginal birth
postpartum haemorrhage
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2014-05-13
Enrollment: 520
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Blood loss 500 ml or more after enrolment
timeFrame: 60 minutes after enrolment
Secondary outcomes:
measure: Blood loss 1000 ml or more after enrolment
timeFrame: (up to 30 and 60 minutes) after enrolment
measure: Use of additional uterotonics or other procedures
timeFrame: 60 minutes
measure: Blood transfusion
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha univesity hospital and afhsa
state: El Qualyobia
Study officials:
affiliation: Department of Obstetrics and Gynecology,AFHSA
name: ibrahim zweel
role: PRINCIPAL_INVESTIGATOR
References: