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

NCTNCT03680339Other id42

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Overview

Status: Completed
Phase: Phase 4
Enrollment: 200 participants (actual)
Sponsor: Cairo University · Other
Design: Randomized · Single masking
Countries: 1 country
Egypt
Start: 2 Sept 2018
Primary completion: 1 Jan 2019
Completion: 28 Jan 2019
First posted: 21 Sept 2018
Last update posted: 27 Jun 2023
Conditions: Post Partum Hemorrhage

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201820192020

Ph 4
The Effect of Preoperative and Post Operative Misoprostol Administration on Intraoperative Blood Loss and Postpartum Hemorrhage in CS
NCT03680339
2 Sept 2018 to 28 Jan 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

• 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

Interventions

cesarean sectionProcedure
MisoprostolDrug
OxytocinDrug

Arms2

Active comparator
Routine ecbolic group
100 patients will receive routine ecbolics ( oxytocin) after delivery of baby
Active comparator
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

Primary outcomes1

Outcomes the sponsor listed as primary.

postpartum hemorrhage
Time frame · 24 hours after cesarean section

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedMaged 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. PMID 31304593

Eligibility

Who could join, as posted.

Sex: Female
Age: from 20 Years up to 35 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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