CClinicalTrials.gg
Status unknownNCT03463070Updated Mar 13, 2018

Misoprostol Before and After Cesarean Section

A Phase 3 interventional study of rectal misoprostol 600mg in Post Partum Hemorrhage, sponsored by sarah mohamed hassan. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2018-03-13.

Sponsored by sarah mohamed hassan · Phase 3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
Female
01

Study summary

comparison of the effect of misoprostol before and after cesarean on the blood loss

Read the detailed description

70 women who received 600 mg misoprostol rectally preoperatively versus 70 women who received 600 mg misoprostol postoperatively at operating theatre

02

Conditions studied

  • Post Partum Hemorrhage

Keywords

  • misoprostol
  • postpartum haemorrhage
03

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Women not in active labor have reactive non-stress test.
  • No contraindications to prostaglandins.
  • Have no history of coagulopathy.

Exclusion criteria

Exclusion Criteria:

  • Placenta previa.
  • Maternal hypertension.
  • Diabetes mellitus.
  • Previous CS and those with active labor.
  • Multiple Fibroid uterus.
  • Multiple pregnancies or polyhydramnios.
  • Previous myomectomy, previous history of PPH.
04

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
140 participants (estimated)

Study arms

  • Active comparator
    preoperative misoprostol group

    70 women who received 600 mg misoprostol rectally preoperatively before cesarean section

    Drug: rectal misoprostol 600mg

  • Active comparator
    postoperative misoprostol group

    70 women who received 600 mg misoprostol postoperatively at operating theatre after cesarean section

    Drug: rectal misoprostol 600mg

Interventions

  • Drugrectal misoprostol 600mg

    70 women who received 600 mg misoprostol postoperatively at operating theatre

05

What researchers measure

Primary outcomes

  1. intraoperative blood loss

    Difference in weight of linen towels (gm)+Volume of contents of suction bottle (ml)

    Time frame: the operation time

  2. postoperative blood loss

    weighing the soaked napkins after collection of soaked towel

    Time frame: every 6 hours during first 24 hours.

06

Study locations

1 site
  • Kasr El Ainiy Hospital
    Cairo, 11562, Egypt
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03463070
Lead sponsor
sarah mohamed hassan
Responsible party
sarah mohamed hassan (lecturer of obstetrics and gynecology, Kasr El Aini Hospital) — Sponsor-investigator
First posted
Mar 13, 2018
Start date
Mar 2018 (estimated)
Primary completion
Sep 2018 (estimated)
Completion
Sep 2018 (estimated)
Last update
Mar 13, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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