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
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Haemorrhage||Procedure: bimanual uterine compression||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||520 participants|
|Intervention Model:||Parallel Assignment|
|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|
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).
- Blood loss 500 ml or more after enrolment [ Time Frame: 60 minutes after enrolment ]estimating blood loss from vagina
- Blood loss 1000 ml or more after enrolment [ Time Frame: (up to 30 and 60 minutes) after enrolment ]estimating blood loss by collecting it
- Use of additional uterotonics or other procedures [ Time Frame: 60 minutes ]giving drugs IV
- Blood transfusion [ Time Frame: 60 minutes ]giving how many units of PRBCS
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
|Contact: khalid ibrahim, MDfirstname.lastname@example.org|
|Contact: ibrahim email@example.com|
|Benha univesity hospital and afhsa||Recruiting|
|Banhā, El Qualyobia, Egypt, 13518|
|Contact: khalid mohamed 201281469651 firstname.lastname@example.org|
|Principal Investigator: ibrahim zweel, MD|
|Principal Investigator:||ibrahim zweel||Department of Obstetrics and Gynecology,AFHSA|