Postpartum HemorrhageNCT07188207
Rectal Misoprostol for Reducing Blood Loss in Elective Cesarean Section
A study testing Oxytocin in people with Postpartum Hemorrhage, run by Assiut University.
Trial summary
This randomized controlled trial aims to evaluate the efficacy of adding preoperative rectal misoprostol to standard oxytocin for reducing intraoperative and postoperative blood loss in women undergoing elective cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-45 years.
- Singleton pregnancy at ≥37 weeks of gestation.
- Elective cesarean section planned under spinal anesthesia.
- Hemodynamically stable prior to surgery.
- Provided written informed consent.
Who cannot join
- Multiple pregnancy.
- Antepartum hemorrhage (e.g., placenta previa, abruption).
- Coagulopathy, thrombocytopenia, or anticoagulant therapy.
- Severe medical comorbidities (e.g., uncontrolled hypertension, cardiac disease, hepatic or renal impairment).
- Known allergy or contraindication to prostaglandins or oxytocin.
- Intrauterine fetal death or major fetal anomaly.
- Refusal to participate.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Efficacy of Adding Preoperative Rectal Misoprostol for Decreasing Intraoperative and Postoperative Blood Loss at Elective Cesarean Section
This randomized controlled trial aims to evaluate the efficacy of adding preoperative rectal misoprostol to standard oxytocin for reducing intraoperative and postoperative blood loss in women undergoing elective cesarean section. Misoprostol is a prostaglandin E1 analogue that is inexpensive, heat-stable, and effective as a uterotonic agent. The study will compare outcomes between two groups: women receiving oxytocin alone and women receiving oxytocin plus rectal misoprostol. The primary outcome is the reduction of blood loss during and after surgery. Secondary outcomes include changes in hemoglobin levels, need for additional uterotonics, maternal safety, and overall recovery.
Read the detailed description
Postpartum hemorrhage (PPH) is a leading cause of maternal morbidity and mortality worldwide, with increased risk following cesarean section compared to vaginal delivery. Oxytocin is the standard uterotonic agent used to prevent PPH, but it has several limitations including the need for refrigeration and potential cardiovascular side effects when administered rapidly.
Misoprostol, a prostaglandin E1 analogue, has gained attention as an effective alternative or adjunct to oxytocin because it is heat-stable, inexpensive, widely available in tablet form, and can be administered by various routes. The rectal route is particularly advantageous, providing rapid absorption, sustained uterine contraction, and fewer gastrointestinal side effects. However, its onset of action is slower than oxytocin, which may affect intraoperative hemostasis if uterine tone is not achieved quickly.
This study is designed as a randomized controlled trial conducted at the Department of Obstetrics and Gynecology, Assiut University Hospital. Eligible participants will be women aged 18-45 years with singleton pregnancies at ≥37 weeks of gestation undergoing elective cesarean section. Participants will be randomized into two groups:
Group A (Control): Oxytocin only, given according to hospital protocol immediately after delivery of the baby and placenta.
Group B (Intervention): Oxytocin plus a single rectal dose of misoprostol (600-1000 µg, based on risk profile) administered immediately after delivery of the baby and placenta.
The primary outcome will be the reduction in intraoperative and postoperative blood loss. Secondary outcomes will include changes in pre- and postoperative hemoglobin levels, need for additional uterotonic agents, maternal safety, ease and feasibility of rectal administration, and postoperative recovery.
The total sample size is 282 participants (141 per group), calculated to provide 80% power at a 95% confidence level to detect a significant reduction in blood loss. Data will be analyzed using SPSS software, with chi-square and independent sample t-tests applied as appropriate. Statistical significance will be considered at p < 0.05.
This trial seeks to provide evidence on the effectiveness and practicality of rectal misoprostol as an adjunct to oxytocin for reducing maternal blood loss during elective cesarean section, potentially improving outcomes and cost-effectiveness, particularly in resource-limited settings.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Oxytocin
- Keywords
- Misoprostol, Oxytocin, Cesarean Delivery
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Intravenous oxytocin administered per hospital protocol immediately after delivery of the baby and placenta (example regimen: 10 IU slow IV bolus followed by infusion e.g., 20 IU in 500-1000 mL isotonic crystalloid run over 2-4 hours; actual dosing adjusted per anesthesiologist/obstetrician and hospital policy). Document exact time, dose, and infusion rate in each case.
Single rectal dose of misoprostol 600-1000 µg (select dose based on patient risk profile; e.g., 600 µg for routine prophylaxis, 800-1000 µg for high-risk cases) inserted into the rectum immediately after delivery of the baby and placenta. No dilution required.
| Study group | Role | What they receive |
|---|---|---|
| Control: Oxytocin only | Experimental | Description: Participants receive standard intraoperative uterotonic therapy with oxytocin according to hospital protocol immediately after delivery of the baby and placenta. Standard perioperative care (spinal anesthesia, prophylactic antibiotics, fluid management, monitoring) is provided. Rescue uterotonic measures and transfusion given as clinically indicated. Receives: Drug: Oxytocin |
| Intervention: Oxytocin + Rectal Misoprostol | Experimental | Participants receive the same oxytocin regimen as Arm 1 plus a single rectal dose of misoprostol (600-1000 µg depending on risk profile) administered immediately after delivery of the baby and placenta. Standard perioperative care is identical to Arm 1. Rescue uterotonic measures and transfusion given as clinically indicated. Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative and postoperative blood loss
Total blood loss will be measured intraoperatively by suction canister volume (minus irrigation fluid) and gravimetric method (weighing surgical pads/swabs), and postoperatively by weighing perineal pads up to 24 hours.
Measured: From skin incision until 24 hours after cesarean delivery
Secondary outcomes (1)
Change in Hemoglobin and Hematocrit
Difference between pre- and postoperative hemoglobin/hematocrit values to estimate blood loss.
Measured: Preoperative (within 24 hours before surgery) and 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Model description
- Participants will be randomly assigned into two equal parallel groups: one receiving oxytocin alone (control group), and the other receiving oxytocin plus rectal misoprostol (intervention group).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Zanaty Khalaf Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188207
- Sponsor's protocol ID
- MISOCS-2025
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Federspiel JJ, Eke AC, Eppes CS. Postpartum hemorrhage protocols and benchmarks: improving care through standardization. Am J Obstet Gynecol MFM. 2023 Feb;5(2S):100740. doi: 10.1016/j.ajogmf.2022.100740. Epub 2022 Sep 2.
PubMed 36058518
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Adding Preoperative Rectal Misoprostol for Decreasing Intraoperative and Postoperative Blood Loss at Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT07188207
- Acronym / sponsor ID
- MISOCS-2025
- Conditions
- Postpartum Hemorrhage
- Keywords
- Misoprostol, Oxytocin, Cesarean Delivery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Sep 2025 (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.
This randomized controlled trial aims to evaluate the efficacy of adding preoperative rectal misoprostol to standard oxytocin for reducing intraoperative and postoperative blood loss in women undergoing elective cesarean section. Misoprostol is a prostaglandin E1 analogue that is inexpensive, heat-stable, and effective as a uterotonic agent. The study will compare outcomes between two groups: women receiving oxytocin alone and women receiving oxytocin plus rectal misoprostol. The primary outcome is the reduction of blood loss during and after surgery. Secondary outcomes include changes in hemoglobin levels, need for additional uterotonics, maternal safety, and overall recovery.
Detailed description
Postpartum hemorrhage (PPH) is a leading cause of maternal morbidity and mortality worldwide, with increased risk following cesarean section compared to vaginal delivery. Oxytocin is the standard uterotonic agent used to prevent PPH, but it has several limitations including the need for refrigeration and potential cardiovascular side effects when administered rapidly.
Misoprostol, a prostaglandin E1 analogue, has gained attention as an effective alternative or adjunct to oxytocin because it is heat-stable, inexpensive, widely available in tablet form, and can be administered by various routes. The rectal route is particularly advantageous, providing rapid absorption, sustained uterine contraction, and fewer gastrointestinal side effects. However, its onset of action is slower than oxytocin, which may affect intraoperative hemostasis if uterine tone is not achieved quickly.
This study is designed as a randomized controlled trial conducted at the Department of Obstetrics and Gynecology, Assiut University Hospital. Eligible participants will be women aged 18-45 years with singleton pregnancies at ≥37 weeks of gestation undergoing elective cesarean section. Participants will be randomized into two groups:
Group A (Control): Oxytocin only, given according to hospital protocol immediately after delivery of the baby and placenta.
Group B (Intervention): Oxytocin plus a single rectal dose of misoprostol (600-1000 µg, based on risk profile) administered immediately after delivery of the baby and placenta.
The primary outcome will be the reduction in intraoperative and postoperative blood loss. Secondary outcomes will include changes in pre- and postoperative hemoglobin levels, need for additional uterotonic agents, maternal safety, ease and feasibility of rectal administration, and postoperative recovery.
The total sample size is 282 participants (141 per group), calculated to provide 80% power at a 95% confidence level to detect a significant reduction in blood loss. Data will be analyzed using SPSS software, with chi-square and independent sample t-tests applied as appropriate. Statistical significance will be considered at p < 0.05.
This trial seeks to provide evidence on the effectiveness and practicality of rectal misoprostol as an adjunct to oxytocin for reducing maternal blood loss during elective cesarean section, potentially improving outcomes and cost-effectiveness, particularly in resource-limited settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned into two equal parallel groups: one receiving oxytocin alone (control group), and the other receiving oxytocin plus rectal misoprostol (intervention group).
| Arm | Type | Receives |
|---|---|---|
| Control: Oxytocin only | Experimental | Drug: OxytocinDescription: Participants receive standard intraoperative uterotonic therapy with oxytocin according to hospital protocol immediately after delivery of the baby and placenta. Standard perioperative care (spinal anesthesia, prophylactic antibiotics, fluid management, monitoring) is provided. Rescue uterotonic measures and transfusion given as clinically indicated. |
| Intervention: Oxytocin + Rectal Misoprostol | Experimental | Drug: OxytocinParticipants receive the same oxytocin regimen as Arm 1 plus a single rectal dose of misoprostol (600-1000 µg depending on risk profile) administered immediately after delivery of the baby and placenta. Standard perioperative care is identical to Arm 1. Rescue uterotonic measures and transfusion given as clinically indicated. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged 18-45 years.
- Singleton pregnancy at ≥37 weeks of gestation.
- Elective cesarean section planned under spinal anesthesia.
- Hemodynamically stable prior to surgery.
- Provided written informed consent.
Key exclusion criteria (7 listed)
- Multiple pregnancy.
- Antepartum hemorrhage (e.g., placenta previa, abruption).
- Coagulopathy, thrombocytopenia, or anticoagulant therapy.
- Severe medical comorbidities (e.g., uncontrolled hypertension, cardiac disease, hepatic or renal impairment).
- Known allergy or contraindication to prostaglandins or oxytocin.
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 |
|---|---|---|
| OxytocinIntravenous oxytocin administered per hospital protocol immediately after delivery of the baby and placenta (example regimen: 10 IU slow IV bolus followed by infusion e.g., 20 IU in 500-1000 mL isotonic crystalloid run over 2-4 hours; actual dosing adjusted per anesthesiologist/obstetrician and hospital policy). Document exact time, dose, and infusion rate in each case. Single rectal dose of misoprostol 600-1000 µg (select dose based on patient risk profile; e.g., 600 µg for routine prophylaxis, 800-1000 µg for high-risk cases) inserted into the rectum immediately after delivery of the baby and placenta. No dilution required. | Drug | Control: Oxytocin only, Intervention: Oxytocin + Rectal Misoprostol |
Primary outcome
Intraoperative and postoperative blood loss
Time frame: From skin incision until 24 hours after cesarean delivery
Total blood loss will be measured intraoperatively by suction canister volume (minus irrigation fluid) and gravimetric method (weighing surgical pads/swabs), and postoperatively by weighing perineal pads up to 24 hours.
1 secondary outcome
Change in Hemoglobin and Hematocrit
Time frame: Preoperative (within 24 hours before surgery) and 24 hours postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Results publication: PubMed 36058518Federspiel JJ, Eke AC, Eppes CS. Postpartum hemorrhage protocols and benchmarks: improving care through standardization. Am J Obstet Gynecol MFM. 2023 Feb;5(2S):100740. doi: 10.1016/j.ajogmf.2022.100740. Epub 2022 Sep 2.
- Individual participant dataSharing planned: No
Related trials for Postpartum Hemorrhage
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
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.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Postpartum Hemorrhage, run by Assiut University.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact amira zanaty khalaf, resident (01004231328, amirazanatya@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative and postoperative blood loss (time frame: From skin incision until 24 hours after cesarean delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07188207, which also lists 1 linked publication.
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 23 Sep 2025.