ClinicalTrials.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verified this record recently (last verified Mar 2018), so the status shown — last known as Not yet recruiting — may be out of date.

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Phase
Phase 3
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 59 studies testing misoprostol in Postpartum Hemorrhage — 2 open to participants now, 2 under way, 1 of them phase 3. Misoprostol · Postpartum Hemorrhage.

Planned enrollment
44th of 59
140 · median 240
Started
2018
with 8 others
Phase 3
10 of 59
1 open now
Registered
38th of 59
by date

Among the 59 studies testing misoprostol in Postpartum Hemorrhage, this one is the 44th largest by planned enrollment, is one of 9 that started in 2018, is one of 10 in phase 3, and was the 38th registered.

Postpartum Hemorrhage

469 studies on the registry are indexed under Postpartum Hemorrhage; 76 are open to participants now.

Browse Postpartum Hemorrhage studies →

Open to participants now

2 of the 59 studies testing misoprostol in Postpartum Hemorrhage are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

About misoprostol

Misoprostol: first FDA approval 1988 (CYTOTEC). What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 42 Postpartum Hemorrhage studies recruiting now, 21 (50%) set no upper age limit and 21 (50%) stop at 75 or younger; 6 take children under 18; 21 take healthy volunteers.

This study: 20 Years to 35 Years · female · no healthy volunteers.

The full table on the hub →

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02

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

03

Conditions studied

  • Post Partum Hemorrhage

Browse trials for

Keywords

  • misoprostol
  • postpartum haemorrhage
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women not in active labor have reactive non-stress test.
  • No 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

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

06

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.

07

Study locations

1 site
  • Kasr El Ainiy Hospital
    Cairo, 11562, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2018; primary completion for Sep 2018, 6 months later.

Of 20 phase 3 interventional studies under Postpartum Hemorrhage, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 38. This study's planned 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 4, 2018
First posted
Mar 13, 2018
StartEst.
Mar 2018
Primary completionEst.
Sep 2018
CompletionEst.
Sep 2018
Last update
Mar 13, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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Discussion

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Studies of the drug tested here: Misoprostol

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