Postpartum Hemorrhage， Cesarean SectionNCT07728084
A Comparative Study Between Rectal and Intrauterine Misoprostol Administration in the Reduction of Blood Loss During and After Elective Cesarean Delivery in Low Risk Women
A study testing Misoprostol Tabets in people with Postpartum Hemorrhage， Cesarean Section, run by Cairo University at 1 site in Egypt.
Trial summary
One hundred forty low risk pregnant women scheduled for elective cesarean delivery were randomized (1:1) into two groups: the intrauterine group (n=70) received 400 μg misoprostol (200 μg at each uterine cornu) after placental delivery, while the rectal group (n=70) received 400 μg misoprostol rectally via urinary… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Postpartum Hemorrhage， Cesarean Section
- What is being tested?
- Misoprostol Tabets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Jan 2025to 29 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Low risk women with singleton living fetus scheduled for elective cesarean delivery
- American Society of Anesthesiologists (ASA) physical status I or II
- Age: 20-40 years
- Parity: 0-3
- Gestational age: 37-40 completed weeks
- Body mass index (BMI): 18-30 kg/m²
- Planned spinal anesthesia
- Provision of informed consent
Who cannot join
- High risk pregnancies (anemia, renal disease, cardiac disease, hepatic disease, coagulopathies)
- Increased risk for obstetric hemorrhage (placenta previa, placenta accreta spectrum, polyhydramnios, history of PPH, uterine rupture, uterine fibroids)
- Allergy to prostaglandins or prostaglandin contraindications (e.g., asthma)
- Complicated cesarean sections (bladder/ureteric injury, intestinal injury, massive intraoperative bleeding)
- Known fetal or structural anomalies
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between Rectal and Intrauterine Misoprostol Administration in the Reduction of Blood Loss During and After Elective Cesarean Delivery in Low Risk Women: A Randomized Controlled Trial
One hundred forty low risk pregnant women scheduled for elective cesarean delivery were randomized (1:1) into two groups: the intrauterine group (n=70) received 400 μg misoprostol (200 μg at each uterine cornu) after placental delivery, while the rectal group (n=70) received 400 μg misoprostol rectally via urinary catheter insertion preoperatively.
Read the detailed description
Intrauterine Misoprostol Group (n=70) Participants received 400 μg of misoprostol (Cytotec, Pfizer, G.D. Searle LLC) administered intrauterinely after placental delivery during cesarean section. The dose was divided as 200 μg placed at each uterine cornu.
Rectal Misoprostol Group (n=70) Participants received 400 μg of misoprostol (Cytotec, Pfizer, G.D. Searle LLC) administered rectally via urinary catheter insertion preoperatively Standard Care All participants received standard active management of the third stage of labor including: Intravenous bolus of 5 IU oxytocin after fetal delivery 20 IU oxytocin diluted in 500 mL lactated Ringer's solution infused at 125 mL/hour Surgical Protocol All cesarean deliveries were performed under spinal anesthesia using a standardized surgical technique
- Conditions
- Postpartum Hemorrhage， Cesarean Section
- Being tested
- Misoprostol Tabets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol TabetsDrug
400 μg of misoprostol administered intrauterinely after placental delivery during cesarean section
Misoprostol TabetsDrug
400 μg of misoprostol (Cytotec, Pfizer, G.D. Searle LLC) administered rectally via urinary catheter insertion preoperatively
| Study group | Role | What they receive |
|---|---|---|
| Intrauterine Misoprostol | Active comparator | 400 μg of misoprostol (Cytotec, Pfizer, G.D. Searle LLC) administered intrauterinely after placental delivery during cesarean section. The dose was divided as 200 μg placed at each uterine cornu. Receives: Drug: Misoprostol Tabets |
| Rectal Misoprostol | Active comparator | 400 μg of misoprostol administered rectally via urinary catheter insertion preoperatively. Receives: Drug: Misoprostol Tabets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated intraoperative blood loss
Combined blood from suction and soaked materials
Measured: at time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start13 Jan 2025
- Primary completion25 Apr 2026
- Study completion29 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Hemorrhage， Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed Maged, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728084
- Sponsor's protocol ID
- 370
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Rectal and Intrauterine Misoprostol Administration in the Reduction of Blood Loss During and After Elective Cesarean Delivery in Low Risk Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07728084
- Acronym / sponsor ID
- 370
- Conditions
- Postpartum Hemorrhage， Cesarean Section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 25 Apr 2026 (actual)
- Study completion
- 29 Jun 2026 (actual)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One hundred forty low risk pregnant women scheduled for elective cesarean delivery were randomized (1:1) into two groups: the intrauterine group (n=70) received 400 μg misoprostol (200 μg at each uterine cornu) after placental delivery, while the rectal group (n=70) received 400 μg misoprostol rectally via urinary catheter insertion preoperatively.
Detailed description
Intrauterine Misoprostol Group (n=70) Participants received 400 μg of misoprostol (Cytotec, Pfizer, G.D. Searle LLC) administered intrauterinely after placental delivery during cesarean section. The dose was divided as 200 μg placed at each uterine cornu.
Rectal Misoprostol Group (n=70) Participants received 400 μg of misoprostol (Cytotec, Pfizer, G.D. Searle LLC) administered rectally via urinary catheter insertion preoperatively Standard Care All participants received standard active management of the third stage of labor including: Intravenous bolus of 5 IU oxytocin after fetal delivery 20 IU oxytocin diluted in 500 mL lactated Ringer's solution infused at 125 mL/hour Surgical Protocol All cesarean deliveries were performed under spinal anesthesia using a standardized surgical technique
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrauterine Misoprostol | Active comparator | Drug: Misoprostol Tabets400 μg of misoprostol (Cytotec, Pfizer, G.D. Searle LLC) administered intrauterinely after placental delivery during cesarean section. The dose was divided as 200 μg placed at each uterine cornu. |
| Rectal Misoprostol | Active comparator | Drug: Misoprostol Tabets400 μg of misoprostol administered rectally via urinary catheter insertion preoperatively. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Low risk women with singleton living fetus scheduled for elective cesarean delivery
- American Society of Anesthesiologists (ASA) physical status I or II
- Age: 20-40 years
- Parity: 0-3
- Gestational age: 37-40 completed weeks
Key exclusion criteria (6 listed)
- High risk pregnancies (anemia, renal disease, cardiac disease, hepatic disease, coagulopathies)
- Increased risk for obstetric hemorrhage (placenta previa, placenta accreta spectrum, polyhydramnios, history of PPH, uterine rupture, uterine fibroids)
- Allergy to prostaglandins or prostaglandin contraindications (e.g., asthma)
- Complicated cesarean sections (bladder/ureteric injury, intestinal injury, massive intraoperative bleeding)
- Known fetal or structural anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Misoprostol Tabets400 μg of misoprostol administered intrauterinely after placental delivery during cesarean section | Drug | Intrauterine Misoprostol |
| Misoprostol Tabets400 μg of misoprostol (Cytotec, Pfizer, G.D. Searle LLC) administered rectally via urinary catheter insertion preoperatively | Drug | Rectal Misoprostol |
Primary outcome
Estimated intraoperative blood loss
Time frame: at time of surgery
Combined blood from suction and soaked materials
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Maged principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol Tabets in people with Postpartum Hemorrhage， Cesarean Section, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated intraoperative blood loss (time frame: at time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.