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Completed

NCT Number: NCT01412073

Control of Blood Loss During Caesarean Section

trial of 3 protocols to determine the best one to control blood loss during caesarean section

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Key information

Conditions

Complications; Cesarean Section

Age range

25 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

faculty of medicine , Cairo University

Cairo, Cairo Governorate, 12211, Egypt

About this study

The study population will be divided into 3 groups each containing 200 women:

Group (A): 200 patients will receive 5-IU oxytocin bolus over 3 minutes after delivery of the baby.

Group (B): 200 patients will receive 5-IU oxytocin bolus over 3 minutes and 30-IU oxytocin infusion in 500 ml 0.9 % saline over 4 hours after delivery of the baby.

Group (C): 200 patients will receive misoprostol 800 micrograms intrauterine, placed manually on the bottom of the uterine cavity after delivery of the placenta and cleaning of the cavity.

Operative blood loss will be estimated in theatre based on the volume in the suction bottle and the weight of swabs used. We will record blood loss up until the time the woman will be discharged from the theatre recovery ward.

Hemoglobin level and haematocrit value will be done as follow:-

  • After admission of each case in the pre-operative period.
  • Immediately post- operative.
  • 24 hours post- operative.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients booked for elective cesarean section.
  • Singleton pregnancies.
  • Primigravida or multipara ,first cesarean section or previous .

Exclusion criteria

  • Patients with obstetric hemorrhage.
  • Uterine laceration.
  • Placenta previa.
  • Blood dyscrasias.
  • Large fibroids.
  • Multiple pregnancy.
  • Pre-eclampsia.
  • Marked maternal anemia.
  • Previous history of PPH.

Treatment and study plan

Oxytocin

Drug

group I : oxytocin 5 IU bolus over 3 minutes after delivery of the baby group II : oxytocin 5 IU bolus over 3 minutes after delivery of the baby and oxytocin infusion in 500 ml 0.9% saline over 4 hours

Other names: syntocinon

Misoprostol

Drug

misoprostol intrauterine 800 microgram placed intrauterine after delivery of the baby & the placenta

Other names: cytotec

Primary outcomes

  1. amount of blood loss

    Time frame: 12 month

Secondary outcomes

  1. Haemoglobin % and haematocrit value

    Time frame: 12 month

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

A Randomized Trial to Determine the Best Strategy for the Control of Blood Loss at Elective Caesarean Section

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 8, 2011
Registry last updated
Oct 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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