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

Primary Purpose

Postpartum Haemorrhage

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

misoprostol

placeboo

Sponsored by

Ain Shams University

About this trial

This is an interventional prevention trial for Postpartum Haemorrhage

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Faculty of Medicine, Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

misoprostol

placeboo

Arm Description

women receiving pre-operative rectally administered 400 microgram misoprostol

women receiving placebo

Outcomes

Primary Outcome Measures

volume of intraoperative blood loss

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 Outcome Measures

maternal mortality

mean measured blood loss

placental retention

when the placenta is not delivered spontaneously for 30 minutes

requirement for blood transfusion

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

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

postpartum hemoglobin

less than 10gm%

mean postpartum hematocrit

more than 10% drop in the postpartum hematocrit

Full Information

NCT ID

First Posted

July 24, 2015

Last Updated

November 9, 2016

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT02509351

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

October 2015 (undefined)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postpartum Haemorrhage

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

280 (Actual)

8. Arms, Groups, and Interventions

Arm Title

misoprostol

Arm Type

Experimental

Arm Description

women receiving pre-operative rectally administered 400 microgram misoprostol

Arm Title

placeboo

Arm Type

Active Comparator

Arm Description

women receiving placebo

Intervention Type

Drug

Intervention Name(s)

misoprostol

Other Intervention Name(s)

mesotac

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placeboo

Other Intervention Name(s)

control

Intervention Description

women will recive 2 identical tablets as placeboo

Primary Outcome Measure Information:

Title

volume of intraoperative blood loss

Description

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

Time Frame

30 minute

Secondary Outcome Measure Information:

Title

maternal mortality

Time Frame

6 months

Title

mean measured blood loss

Time Frame

1, 2, and 24 h postpartum

Title

placental retention

Description

when the placenta is not delivered spontaneously for 30 minutes

Time Frame

30 minutes

Title

requirement for blood transfusion

Description

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

Time Frame

24 hours

Title

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

Time Frame

24 hours

Title

postpartum hemoglobin

Description

less than 10gm%

Time Frame

24 hours

Title

mean postpartum hematocrit

Description

more than 10% drop in the postpartum hematocrit

Time Frame

24 hours

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Helmy Dr metawe, MD

Organizational Affiliation

Ain Shams University

Official's Role

Study Chair

Facility Information:

Facility Name

Faculty of Medicine, Ain Shams University

City

Cairo

State/Province

Al Qahirah

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

No

Learn more about this trial

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

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