Postpartum HemorrhagePhase 4NCT06970483
Comparison of the Efficacy of Misoprostol and Tranexamic Acid for Postpartum Hemorrhage Prophylaxis in Cesarean Delivery
A Phase 4 study testing Tranexamic acid and Misoprostol 200mcg Tab in people with Postpartum Hemorrhage and Cesarean Section Complications, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Postpartum hemorrhage (PPH) is an obstetric emergency, with an estimated incidence ranging from 2.8% to 7.9%. Recent studies indicate an increasing trend in the frequency of PPH.Although it is more commonly seen in developing countries, it remains a significant cause of maternal morbidity and mortality worldwide. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage, Cesarean Section Complications, Delivery Complication
- What is being tested?
- Tranexamic acid and Misoprostol 200mcg Tab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 1 Dec 2024
- Phase
- Phase 4
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 18-45 years Gestational age between 37 and 41 weeks Prior cesarean delivery (repeat elective cesarean section) Performed cesarean section for delivery
Who cannot join
- did not provide informed consent,
- with comorbidities (such as heart, liver, or lung diseases),
- high-risk pregnancy (e.g., intrauterine growth restriction, cholestasis, preeclampsia, eclampsia, multiple pregnancies)
- known allergies to tranexamic acid or misoprostol
- known coagulation disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy of Sublingual Misoprostol and Intravenous Tranexamic Acid for Postpartum Hemorrhage Prophylaxis in Cesarean Delivery
Postpartum hemorrhage (PPH) is an obstetric emergency, with an estimated incidence ranging from 2.8% to 7.9%. Recent studies indicate an increasing trend in the frequency of PPH.Although it is more commonly seen in developing countries, it remains a significant cause of maternal morbidity and mortality worldwide. Therefore, early diagnosis and prompt, accurate intervention are critically important.
Despite the rising incidence of PPH, maternal mortality rates have declined. This improvement is largely attributed to better identification of risk factors, timely diagnosis, and effective intervention.
Read more
To prevent PPH globally, active management of the third stage of labor has been widely implemented. This approach includes the use of pharmacologic agents, uterine massage, and controlled traction for placental delivery.Among pharmacological agents, the most commonly used include oxytocin, ergot alkaloids (e.g., ergometrine), tranexamic acid, prostaglandin E1 (misoprostol), prostaglandin F2α, and oxytocin analogues (e.g., carbetocin).Oxytocin is the most widely used agent for PPH prophylaxis.
The aim of this study is to compare the efficacy of tranexamic acid and misoprostol in the prophylaxis of postpartum hemorrhage.
Read the detailed description
The study included elective cases scheduled for repeat cesarean delivery (women with a prior cesarean delivery) at the Obstetrics and Gynecology Clinic, Maternity Ward of Etlik City Hospital, between December 2023 and December 2024.
Patients were divided into three groups. Group 1 received tranexamic acid (Transamin 10% ampoule, 2.5 mL/250 mg, Actavis Pharmaceuticals, Turkey); 1 gram was administered intravenously during the lower uterine segment incision. Group 2 received misoprostol (Cytotec, 200 mcg tablet, Pfizer Inc., USA); 400 mcg were administered sublingually immediately after delivery and cord clamping. Group 3 (control) received no additional pharmacological agent. All patients received 20 IU oxytocin (Synpitan Forte, 5 IU/mL ampoule, IM/IV, Deva Holding A.Ş., Turkey).
Despite treatment, in cases of intraoperative or postoperative hemorrhage due to uterine atony, additional interventions were performed (additional oxytocin, Bakri balloon, uterine/hypogastric artery ligation, B-Lynch/Hayman sutures, or hysterectomy); these patients were excluded from the final analysis.
Parameters examined: operative time; preoperative and 24-hour postoperative hemoglobin and hematocrit; pulse rate and shock index at 0 and 24 hours; postoperative complications; and blood transfusion requirement.
Sample size was estimated using G*Power 3.1. With α = 0.05, 80% power, and three study arms, the required sample size was calculated as 156 participants (52 per group). Seventy participants were initially enrolled per group to allow for losses; after exclusions, 192 participants (60 misoprostol, 67 TXA, 65 control) were included in the final analysis. Statistical analysis was performed using SPSS version 27. A 95% confidence interval was used, and p < 0.05 was considered statistically significant.
- Being tested
- Tranexamic acid, Misoprostol 200mcg Tab
- Keywords
- postpartum hemmorrhage, ceserean section, maternal complications of delivery, prostoglandine1, tranexamic asid
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called Transamine 10% ampoule, 2.5 mL / 250 mg
Transamine1 gram was administered intravenously during the lower segment incision.
Misoprostol 200mcg TabDrug
Also called Cytotec 200 Mcg Tablet
Cytotec 400 micrograms were administered sublingually immediately after delivery of the baby and clamping of the umbilical cord.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants received routine oxytocin prophylaxis only (Synpitan Forte, 20 IU IM/IV), with no additional pharmacological agent. |
| Misoprostol Group | Experimental | Participants received 400 mcg sublingual misoprostol (Cytotec) immediately after delivery and cord clamping, in addition to routine oxytocin prophylaxis (Synpitan Forte, 20 IU IM/IV). Receives: Drug: Misoprostol 200mcg Tab |
| Tranexamic Acid (TXA) Group | Experimental | Participants received 1 g intravenous tranexamic acid (Transamin) at the time of the lower uterine segment incision, in addition to routine oxytocin prophylaxis (Synpitan Forte, 20 IU IM/IV). Receives: Drug: Tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of patients' preoperative and postoperative hemogram levels
Hemogram values were compared at 0-24 hours postoperatively
Measured: 24 hours
Comparison of patients' preoperative and postoperative hematocrit levels
Hematocrit values were compared at 0-24 hours postoperatively
Measured: 24 hours
Comparison of patients' postoperative shock indices
postoperative shock indices were compared at 0-24 hours postoperatively
Measured: 24 hours
Secondary outcomes (2)
Comparison of the patients' postoperative heart rate
postoperative heart rates were compared at 0-24 hours postoperatively
Measured: 24 hours
operative time
the interval from skin incision to skin closure
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Dec 2023
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients were sequentially assigned (non-randomized, based on order of presentation) to one of three parallel groups. Group 1: tranexamic acid (Transamin) 1 g IV at the lower segment incision. Group 2: misoprostol (Cytotec) 400 mcg sublingual immediately after delivery and cord clamping. All groups additionally received 20 IU oxytocin IM/IV (Synpitan Forte). If hemorrhage occurred intraoperatively or postoperatively despite treatment, additional interventions were performed (extra oxytocin/TXA/misoprostol, Bakri balloon, uterine/hypogastric artery ligation, B-Lynch/Hayman sutures, or hysterectomy)
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tuğba Ağbal, Ankara Etlik City Hospital
- Investigators
- tugba agbal, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970483
- Sponsor's protocol ID
- AEŞH-EK1-2023-774
- Status last verified
- Aug 2026
- First submitted
- 6 May 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Sublingual Misoprostol and Intravenous Tranexamic Acid for Postpartum Hemorrhage Prophylaxis in Cesarean Delivery
- ClinicalTrials.gov ID
- NCT06970483
- Acronym / sponsor ID
- AEŞH-EK1-2023-774
- Keywords
- postpartum hemmorrhage, ceserean section, maternal complications of delivery, prostoglandine1, tranexamic asid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 14 May 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.
Postpartum hemorrhage (PPH) is an obstetric emergency, with an estimated incidence ranging from 2.8% to 7.9%. Recent studies indicate an increasing trend in the frequency of PPH.Although it is more commonly seen in developing countries, it remains a significant cause of maternal morbidity and mortality worldwide. Therefore, early diagnosis and prompt, accurate intervention are critically important.
Despite the rising incidence of PPH, maternal mortality rates have declined. This improvement is largely attributed to better identification of risk factors, timely diagnosis, and effective intervention.
To prevent PPH globally, active management of the third stage of labor has been widely implemented. This approach includes the use of pharmacologic agents, uterine massage, and controlled traction for placental delivery.Among pharmacological agents, the most commonly used include oxytocin, ergot alkaloids (e.g., ergometrine), tranexamic acid, prostaglandin E1 (misoprostol), prostaglandin F2α, and oxytocin analogues (e.g., carbetocin).Oxytocin is the most widely used agent for PPH prophylaxis.
The aim of this study is to compare the efficacy of tranexamic acid and misoprostol in the prophylaxis of postpartum hemorrhage.
Detailed description
The study included elective cases scheduled for repeat cesarean delivery (women with a prior cesarean delivery) at the Obstetrics and Gynecology Clinic, Maternity Ward of Etlik City Hospital, between December 2023 and December 2024.
Patients were divided into three groups. Group 1 received tranexamic acid (Transamin 10% ampoule, 2.5 mL/250 mg, Actavis Pharmaceuticals, Turkey); 1 gram was administered intravenously during the lower uterine segment incision. Group 2 received misoprostol (Cytotec, 200 mcg tablet, Pfizer Inc., USA); 400 mcg were administered sublingually immediately after delivery and cord clamping. Group 3 (control) received no additional pharmacological agent. All patients received 20 IU oxytocin (Synpitan Forte, 5 IU/mL ampoule, IM/IV, Deva Holding A.Ş., Turkey).
Despite treatment, in cases of intraoperative or postoperative hemorrhage due to uterine atony, additional interventions were performed (additional oxytocin, Bakri balloon, uterine/hypogastric artery ligation, B-Lynch/Hayman sutures, or hysterectomy); these patients were excluded from the final analysis.
Parameters examined: operative time; preoperative and 24-hour postoperative hemoglobin and hematocrit; pulse rate and shock index at 0 and 24 hours; postoperative complications; and blood transfusion requirement.
Sample size was estimated using G*Power 3.1. With α = 0.05, 80% power, and three study arms, the required sample size was calculated as 156 participants (52 per group). Seventy participants were initially enrolled per group to allow for losses; after exclusions, 192 participants (60 misoprostol, 67 TXA, 65 control) were included in the final analysis. Statistical analysis was performed using SPSS version 27. A 95% confidence interval was used, and p < 0.05 was considered statistically significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients were sequentially assigned (non-randomized, based on order of presentation) to one of three parallel groups. Group 1: tranexamic acid (Transamin) 1 g IV at the lower segment incision. Group 2: misoprostol (Cytotec) 400 mcg sublingual immediately after delivery and cord clamping. All groups additionally received 20 IU oxytocin IM/IV (Synpitan Forte). If hemorrhage occurred intraoperatively or postoperatively despite treatment, additional interventions were performed (extra oxytocin/TXA/misoprostol, Bakri balloon, uterine/hypogastric artery ligation, B-Lynch/Hayman sutures, or hysterectomy)
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants received routine oxytocin prophylaxis only (Synpitan Forte, 20 IU IM/IV), with no additional pharmacological agent. |
| Misoprostol Group | Experimental | Drug: Misoprostol 200mcg TabParticipants received 400 mcg sublingual misoprostol (Cytotec) immediately after delivery and cord clamping, in addition to routine oxytocin prophylaxis (Synpitan Forte, 20 IU IM/IV). |
| Tranexamic Acid (TXA) Group | Experimental | Drug: Tranexamic acidParticipants received 1 g intravenous tranexamic acid (Transamin) at the time of the lower uterine segment incision, in addition to routine oxytocin prophylaxis (Synpitan Forte, 20 IU IM/IV). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients aged 18-45 years Gestational age between 37 and 41 weeks Prior cesarean delivery (repeat elective cesarean section) Performed cesarean section for delivery
Key exclusion criteria (5 listed)
- did not provide informed consent,
- with comorbidities (such as heart, liver, or lung diseases),
- high-risk pregnancy (e.g., intrauterine growth restriction, cholestasis, preeclampsia, eclampsia, multiple pregnancies)
- known allergies to tranexamic acid or misoprostol
- known coagulation disorders
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 |
|---|---|---|
| Tranexamic acidAlso: Transamine 10% ampoule, 2.5 mL / 250 mgTransamine1 gram was administered intravenously during the lower segment incision. | Drug | Tranexamic Acid (TXA) Group |
| Misoprostol 200mcg TabAlso: Cytotec 200 Mcg TabletCytotec 400 micrograms were administered sublingually immediately after delivery of the baby and clamping of the umbilical cord. | Drug | Misoprostol Group |
Primary outcome
Comparison of patients' preoperative and postoperative hemogram levels
Time frame: 24 hours
Hemogram values were compared at 0-24 hours postoperatively
Comparison of patients' preoperative and postoperative hematocrit levels
Time frame: 24 hours
Hematocrit values were compared at 0-24 hours postoperatively
Comparison of patients' postoperative shock indices
Time frame: 24 hours
postoperative shock indices were compared at 0-24 hours postoperatively
2 secondary outcomes
Comparison of the patients' postoperative heart rate
Time frame: 24 hours
operative time
Time frame: Perioperative
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 6 Aug 2026.
- Individual participant dataSharing planned: No
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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.
tugba agbal principal investigator
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic acid and Misoprostol 200mcg Tab in people with Postpartum Hemorrhage and Cesarean Section Complications, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 5 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 6 Aug 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Comparison of patients' preoperative and postoperative hemogram levels (time frame: 24 hours). The study lists 3 primary outcomes in all. 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 6 Aug 2026.