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Control of Blood Loss During Caesarean Section

Primary Purpose

Complications; Cesarean Section

Status

Completed

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

oxytocin

Misoprostol

About this trial

This is an interventional prevention trial for Complications; Cesarean Section focused on measuring caesarean section, intrapartum haemorrhage

Eligibility Criteria

25 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

faculty of medicine , Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

oxytocin bolus

oxytocin bolus & oxytocin infusion

misoprostol intrauterine

Arm Description

5 IU bolus iv over 3 minutes after delivery of the baby 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.

5 IU oxytoxin bolus over 3 minutes and 30 IU oxytocin infusion in 500 ml 0.9% saline over 4 hours after delivery of the baby

misoprostol 800 micrograms intrauterine, placed manually on the bottom of the uterine cavity after delivery of the placenta and cleaning of the cavity

Outcomes

Primary Outcome Measures

amount of blood loss

Secondary Outcome Measures

Haemoglobin % and haematocrit value

Full Information

NCT ID

NCT01412073

First Posted

August 5, 2011

Last Updated

October 4, 2014

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT01412073

Brief Title

Control of Blood Loss During Caesarean Section

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

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.

6. Conditions and Keywords

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

Complications; Cesarean Section

Keywords

caesarean section, intrapartum haemorrhage

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

600 (Actual)

8. Arms, Groups, and Interventions

Arm Title

oxytocin bolus

Arm Type

Active Comparator

Arm Description

Arm Title

oxytocin bolus & oxytocin infusion

Arm Type

Active Comparator

Arm Description

5 IU oxytoxin bolus over 3 minutes and 30 IU oxytocin infusion in 500 ml 0.9% saline over 4 hours after delivery of the baby

Arm Title

misoprostol intrauterine

Arm Type

Active Comparator

Arm Description

misoprostol 800 micrograms intrauterine, placed manually on the bottom of the uterine cavity after delivery of the placenta and cleaning of the cavity

Intervention Type

Drug

Intervention Name(s)

oxytocin

Other Intervention Name(s)

syntocinon

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Misoprostol

Other Intervention Name(s)

cytotec

Intervention Description

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

Primary Outcome Measure Information:

Title

amount of blood loss

Time Frame

12 month

Secondary Outcome Measure Information:

Title

Haemoglobin % and haematocrit value

Time Frame

12 month

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Waleed M El-khayat, M.D.

Organizational Affiliation

Lecturer of Obstetrics & Gynecology , Faculty of medicine, Cairo University

Official's Role

Study Director

Facility Information:

Facility Name

faculty of medicine , Cairo University

City

Cairo

ZIP/Postal Code

12211

Country

Egypt

12. IPD Sharing Statement

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Control of Blood Loss During Caesarean Section

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