The Effect of Preoperative and Post Operative Misoprostol Administration on Intraoperative Blood Loss and Postpartum Hemorrhage in CS

NCT ID: NCT03680339

Last Updated: 2023-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-02

Study Completion Date

2019-01-28

Brief Summary

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• Patients will be divided into two groups 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen

Then we will compare between two groups regarding

* Intaoperative blood loss
* Risk of Postpartum hemorraghe in the first 24 hrs
* HB pre and postoperative for all patients

Intraoperative blood loss will be estimated by the number and weight of soaked towels and amount of blood in suction unit

Detailed Description

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• Patients will be divided into two groups 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen

Then we will compare between two groups regarding

* Intaoperative blood loss
* Risk of Postpartum hemorraghe in the first 24 hrs
* HB pre and postoperative for all patients

Intraoperative blood loss will be estimated by the number and weight of soaked towels and amount of blood in suction unit

Conditions

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Post Partum Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Routine ecbolic group

100 patients will receive routine ecbolics ( oxytocin) after delivery of baby

Group Type ACTIVE_COMPARATOR

cesarean section

Intervention Type PROCEDURE

CS will be done by pfannenstiel incision , transverse lower uterine segment incision ,immediate cord clamping after delivery of baby , closure of uterus by 2 layers , closure of abdomen in layers

Oxytocin

Intervention Type DRUG

10 IU of oxytocin with fetal delivery

Misoprostol group

The 100 patients will receive routine ecbolics (oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen

Group Type ACTIVE_COMPARATOR

cesarean section

Intervention Type PROCEDURE

CS will be done by pfannenstiel incision , transverse lower uterine segment incision ,immediate cord clamping after delivery of baby , closure of uterus by 2 layers , closure of abdomen in layers

Misoprostol

Intervention Type DRUG

The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen

Oxytocin

Intervention Type DRUG

10 IU of oxytocin with fetal delivery

Interventions

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cesarean section

CS will be done by pfannenstiel incision , transverse lower uterine segment incision ,immediate cord clamping after delivery of baby , closure of uterus by 2 layers , closure of abdomen in layers

Intervention Type PROCEDURE

Misoprostol

The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen

Intervention Type DRUG

Oxytocin

10 IU of oxytocin with fetal delivery

Intervention Type DRUG

Other Intervention Names

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Cytotec

Eligibility Criteria

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Inclusion Criteria

women attending for elective CS.

* Age between 20-35 years.
* Normal placental site
* Normal coagulation profile
* Full term pregnancies(above 37 wks)
* Medically free
* Spinal anesthesia
* Living baby
* Average liquor by U/S

Exclusion Criteria

* • Women attending for emergency CS

* .age below 20 or above 35
* Abnormal placentation (Placenta previa,accrete,increta or percreta)
* Women with coagulopathy
* Preterm pregnancies (before 37 wks)
* Medical disorder (Hypertension,Diabetes, Endocrinal disorder)
* General anathesia
* IUFD
* Oligo or polyhydraminos by U/S
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed M Maged, MD

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed maged, MD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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Kasr Alainy medical school

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Maged AM, Fawzi T, Shalaby MA, Samy A, Rabee MA, Ali AS, Hussein EA, Hammad B, Deeb WS. A randomized controlled trial of the safety and efficacy of preoperative rectal misoprostol for prevention of intraoperative and postoperative blood loss at elective cesarean delivery. Int J Gynaecol Obstet. 2019 Oct;147(1):102-107. doi: 10.1002/ijgo.12922. Epub 2019 Jul 25.

Reference Type DERIVED
PMID: 31304593 (View on PubMed)

Other Identifiers

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42

Identifier Type: -

Identifier Source: org_study_id

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