Clinical Trial: Bimanual Uterine Compression to Reduce Blood Loss and Prevent Postpartum Haemorrhage After Vaginal Delivery
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Bimanual Uterine Compression to Reduce Blood Loss and Prevent Postpartum Haemorrhage After Vaginal Delivery
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 Summary:
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 an
Sponsor: Benha University
Current Primary Outcome: Blood loss 500 ml or more after enrolment [ Time Frame: 60 minutes after enrolment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Benha University
Dates:
Date Received: May 11, 2014
Date Started: April 2014
Date Completion:
Last Updated: May 13, 2017
Last Verified: May 2017
