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Completed

NCT Number: NCT02509351

Could Pre-operative Rectal Misoprostol Reduce Intra-operative Blood Loss During Ceserean Section?

* Misoprostol reduces the uterine bleeding after cesarean delivery without harmful effects on either mother or baby. * The aim of the this study is to address if there is any benefits 'regarding the intra-operative blood loss' from preoperative rectal administration of 400 mic of Misoprostol in addition to the routinely administrated 10 units of oxytocin

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Key information

Conditions

Postpartum Haemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Faculty of Medicine, Ain Shams University

Cairo, Cairo Governorate, Egypt

About this study

Research question:

In women undergoing elective ceserean section, is preoperative 400 mic Misoprostol reduce intra-operative blood loss?

Research hypothesis:

pre-operative Misoprostol doesn't reduce intraoperative blood loss in women undergoing ceserean section

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 38-41 weeks of amenorrhea
  • scheduled for elective lower segment cesarean section

Exclusion criteria

  • confirmed intrauterine fetal death
  • more than previous 2 ceserean sections
  • multiple pregnancy
  • antepartum haemorrhage
  • self-reported maternal heart disease
  • current diagnosis of severe malaria or acute bacterial infection

Treatment and study plan

Misoprostol

Drug

400 microgram of misoprostol is given preoperatively in patients undergoing elective cesarean section

Other names: mesotac

placeboo

Drug

women will recive 2 identical tablets as placeboo

Other names: control

Primary outcomes

  1. volume of intraoperative blood loss

    Time frame: 30 minute

    volume of intraoperative blood loss will be measured in "cc" by a didcated nurse who will use separate suction sets to differentiate between blood and liquor

Secondary outcomes

  1. maternal mortality

    Time frame: 6 months

  2. mean measured blood loss

    Time frame: 1, 2, and 24 h postpartum

  3. placental retention

    Time frame: 30 minutes

    when the placenta is not delivered spontaneously for 30 minutes

  4. requirement for blood transfusion

    Time frame: 24 hours

    indicated per clinical protocol at the study site for mothers with a hemoglobin <100 g/l and/or severe pallor

  5. requirement for additional management of PPH, including therapeutic uterotonic drugs or surgical or radiological procedures

    Time frame: 24 hours

  6. postpartum hemoglobin

    Time frame: 24 hours

    less than 10gm%

  7. mean postpartum hematocrit

    Time frame: 24 hours

    more than 10% drop in the postpartum hematocrit

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Randomized, Placebo-controlled Double Blind Study of Preoperative Misorostol for Reduction of Intraoperative Bleeding in Women Delivered by Ceserean Section

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 28, 2015
Registry last updated
Nov 10, 2016

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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