MisoprostolPhase 4Miso/CSNCT06946914
Misoprostol Before Caesarean Section
A Phase 4 study testing Misoprostol in people with Misoprostol and Respiratory Distress Syndrome (RDS) of Neonate, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The aim of our study is to evaluate the efficacy of Misoprostol before elective cesarean section in pregnant women with gestational age less than 38 weeks for preventing the occurrence of neonatal respiratory morbidity. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Misoprostol, Respiratory Distress Syndrome (RDS) of Neonate, Caesarean Section
- What is being tested?
- Misoprostol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Aug 2025
- Phase
- Phase 4
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with indication for elective caesarean section.
- Age less than 35 years old.
- Gestational age less than 38 weeks.
- Gestational age will be confirmed by certain LMP or reliable early ultrasound measurement of crown-rump length.
- Singleton pregnancy with no major anomalies
Who cannot join
- Any obstetric disorders as preeclampsia and diabetes.
- Fetus with oligohydramnios, intrauterine growth restriction.
- Any contraindications to misoprostol like those with previous allergic reaction or hypersensitivity to prostaglandin hemorrhagic disorders, and severe anemia.
- History of more than or equal 2 previous caesarean section.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kafr El-sheikh University Hospital
Kafr Ash Shaykh, Egypt
Merna Ashraf Ahmed Farid, M.B.B.C.H, 01093030236, mernaashraf2551996@gmail.com
mostafa farag ellkany, MD, 01016083210
About this study
Official title: Misoprostol Administration Before Elective Caesarean Section to Reduce the Risk of Respiratory Morbidity in Newborns
The aim of our study is to evaluate the efficacy of Misoprostol before elective cesarean section in pregnant women with gestational age less than 38 weeks for preventing the occurrence of neonatal respiratory morbidity.
Read the detailed description
Caesarean section is one of the most common carried out surgical procedures in modern obstetrics. About 18.5 million caesarean section are conducted yearly worldwide, and 21-33% of all caesarean section are performed in middle and high-income countries.
The most frequent complications that are seen in neonates include respiratory morbidity, hypoglycemia, sepsis, and admission to the neonatal intensive care unit (NICU). The family and caregivers are affected in many ways when a newborn is admitted to the intensive care unit.
Both preterm and term infants delivered by caesarean section have been reported to experience respiratory distress syndrome, which is brought on by a surfactant deficiency.
Respiratory distress (RD) affects about 27% of babies born, and it is more common in newborns delivered by elective cesarean section (ECS) than in emergency CS or vaginally.
In the neonatal intensive care unit, neonatal respiratory distress syndrome (NRDS), which is mostly brought on by pulmonary surfactant insufficiency after delivery, is acknowledged as one of the most frequent causes of respiratory distress in newborn preterm infants.
In babies with NRDS, pulmonary insufficiency begins after birth and gets worse throughout the course of the first two days of life. Pulmonary surfactant, secreted by type 2 pneumocytes at about 24 weeks gestation, reaches a level that facilitates breathing after birth at 36 weeks.
Misoprostol, an oral medication, an analogue of PGE1, was created and introduced to treat and prevent upper gastrointestinal ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs). Use during pregnancy was not advised because of its uterotonic impact.
Misoprostol was originally licensed for oral use; however, vaginal and sublingual routes of administration are becoming more and more popular supported by pharmacokinetic studies focusing on the systemic bioavailability parameters achieved. While the sublingual route seems to have the greater bioavailability and safety.
Misoprostol's characteristics include being cheap and easily stored at room temperature (shelf life: 3 years). It can be used safely in individuals with hypertension and asthma because, as compared to other prostaglandins, it has less impact on the smooth muscle of the bronchi and cardiovascular system. It is not impacted by the outside temperature and doesn't require syringes, needles, or refrigeration for administration or storage, respectively.
Misoprostol is known as a safe drug with very few side effects. Menstrual cramps, fever, chills, shivering, diarrhea, headaches, and abdominal pain are among its frequent side effects.
Prostaglandins are substances that have been successfully used for labor induction in the pregnant females and the E series being preferred over others due to the fact that they are more utero selective. It was found that prostaglandin has beneficial effects on the neonatal lungs as it causes the reabsorption of lung fluid from the fetal lung and promotes surfactant secretion by inducing the catecholamine surge. However on clinical practice, the effectiveness of the antenatal prophylactic administration prostaglandin on reducing the neonatal respiratory morbidity is still not clear.
Prior studies reported an option for reducing surgical bleeding and their results showed agreement that oxytocin prevented postpartum hemorrhage by helping the uterine contraction. Furthermore, administration of other uterotonic agents have been studied for more effectiveness of treating excessive blood loss. Misoprostol, a prostaglandin E1 analogue, shows a good uterotonic property and less side effects which is available in worldwide even in the low resource setting.
Systematic reviews also demonstrated that misoprostol combined with oxytocin decreased the incidence of PPH significantly. According to their synergistic effects which oxytocin acts immediately with short half-life while misoprostol provides sustainable efficacy of uterine contractility. Misoprostol, in a tablet preparation, can be prescribed in different route including sublingual, oral, rectal and vaginal. In addition, intrauterine insertion is well documented in many studies recently. While an optimal dosage of intrauterine route has not been well established, range of dosage from 400 to 800 μg were used safely. However, side effect such as pyrexia (body temperature ≥ 38 ◦C) was significant high related to higher doses (≥800 μg) of misoprostol was reported .
Various studies have been carried out regarding the incidence and associated factors of respiratory distress in preterm neonates. Such research will be crucial in helping to enhance treatment protocols and raise the infant survival rate, particularly for those neonates who are most at risk of dying from preterm complications like respiratory distress.
- Being tested
- Misoprostol
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
administration of 100mg of misoprostol to evaluate the efficacy of Misoprostol before elective cesarean section in pregnant women with gestational age less than 38 weeks for preventing the occurrence of neonatal respiratory morbidity.
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol before elective cesarean section . | Active comparator | candidates will receive 100mcg Misoprostol one hour before elective caesarean section. Receives: Drug: Misoprostol |
| Giving no treatment before elective caesarean section. | Placebo comparator | candidates will receive no treatment before elective caesarean section. Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of Transient tachypnea of the newborn which defined by increase respiratory rate more than 60 cycle per minute in pregnant women with gestational age less than 38 weeks before elective cesarean section
Measured: in the first 5 minute after delivery of fetus post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 Jun 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MisoprostolStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merna Ashraf Ahmed Farid, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946914
- Sponsor's protocol ID
- KFSIRB200-244
- Acronym
- Miso/CS
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 13 May 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Misoprostol Administration Before Elective Caesarean Section to Reduce the Risk of Respiratory Morbidity in Newborns
- ClinicalTrials.gov ID
- NCT06946914
- Acronym / sponsor ID
- Miso/CS / KFSIRB200-244
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 27 Apr 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.
The aim of our study is to evaluate the efficacy of Misoprostol before elective cesarean section in pregnant women with gestational age less than 38 weeks for preventing the occurrence of neonatal respiratory morbidity.
Detailed description
Caesarean section is one of the most common carried out surgical procedures in modern obstetrics. About 18.5 million caesarean section are conducted yearly worldwide, and 21-33% of all caesarean section are performed in middle and high-income countries.
The most frequent complications that are seen in neonates include respiratory morbidity, hypoglycemia, sepsis, and admission to the neonatal intensive care unit (NICU). The family and caregivers are affected in many ways when a newborn is admitted to the intensive care unit.
Both preterm and term infants delivered by caesarean section have been reported to experience respiratory distress syndrome, which is brought on by a surfactant deficiency.
Respiratory distress (RD) affects about 27% of babies born, and it is more common in newborns delivered by elective cesarean section (ECS) than in emergency CS or vaginally.
In the neonatal intensive care unit, neonatal respiratory distress syndrome (NRDS), which is mostly brought on by pulmonary surfactant insufficiency after delivery, is acknowledged as one of the most frequent causes of respiratory distress in newborn preterm infants.
In babies with NRDS, pulmonary insufficiency begins after birth and gets worse throughout the course of the first two days of life. Pulmonary surfactant, secreted by type 2 pneumocytes at about 24 weeks gestation, reaches a level that facilitates breathing after birth at 36 weeks.
Misoprostol, an oral medication, an analogue of PGE1, was created and introduced to treat and prevent upper gastrointestinal ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs). Use during pregnancy was not advised because of its uterotonic impact.
Misoprostol was originally licensed for oral use; however, vaginal and sublingual routes of administration are becoming more and more popular supported by pharmacokinetic studies focusing on the systemic bioavailability parameters achieved. While the sublingual route seems to have the greater bioavailability and safety.
Misoprostol's characteristics include being cheap and easily stored at room temperature (shelf life: 3 years). It can be used safely in individuals with hypertension and asthma because, as compared to other prostaglandins, it has less impact on the smooth muscle of the bronchi and cardiovascular system. It is not impacted by the outside temperature and doesn't require syringes, needles, or refrigeration for administration or storage, respectively.
Misoprostol is known as a safe drug with very few side effects. Menstrual cramps, fever, chills, shivering, diarrhea, headaches, and abdominal pain are among its frequent side effects.
Prostaglandins are substances that have been successfully used for labor induction in the pregnant females and the E series being preferred over others due to the fact that they are more utero selective. It was found that prostaglandin has beneficial effects on the neonatal lungs as it causes the reabsorption of lung fluid from the fetal lung and promotes surfactant secretion by inducing the catecholamine surge. However on clinical practice, the effectiveness of the antenatal prophylactic administration prostaglandin on reducing the neonatal respiratory morbidity is still not clear.
Prior studies reported an option for reducing surgical bleeding and their results showed agreement that oxytocin prevented postpartum hemorrhage by helping the uterine contraction. Furthermore, administration of other uterotonic agents have been studied for more effectiveness of treating excessive blood loss. Misoprostol, a prostaglandin E1 analogue, shows a good uterotonic property and less side effects which is available in worldwide even in the low resource setting.
Systematic reviews also demonstrated that misoprostol combined with oxytocin decreased the incidence of PPH significantly. According to their synergistic effects which oxytocin acts immediately with short half-life while misoprostol provides sustainable efficacy of uterine contractility. Misoprostol, in a tablet preparation, can be prescribed in different route including sublingual, oral, rectal and vaginal. In addition, intrauterine insertion is well documented in many studies recently. While an optimal dosage of intrauterine route has not been well established, range of dosage from 400 to 800 μg were used safely. However, side effect such as pyrexia (body temperature ≥ 38 ◦C) was significant high related to higher doses (≥800 μg) of misoprostol was reported .
Various studies have been carried out regarding the incidence and associated factors of respiratory distress in preterm neonates. Such research will be crucial in helping to enhance treatment protocols and raise the infant survival rate, particularly for those neonates who are most at risk of dying from preterm complications like respiratory distress.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol before elective cesarean section . | Active comparator | Drug: Misoprostolcandidates will receive 100mcg Misoprostol one hour before elective caesarean section. |
| Giving no treatment before elective caesarean section. | Placebo comparator | Drug: Misoprostolcandidates will receive no treatment before elective caesarean section. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women with indication for elective caesarean section.
- Age less than 35 years old.
- Gestational age less than 38 weeks.
- Gestational age will be confirmed by certain LMP or reliable early ultrasound measurement of crown-rump length.
- Singleton pregnancy with no major anomalies
Key exclusion criteria (4 listed)
- Any obstetric disorders as preeclampsia and diabetes.
- Fetus with oligohydramnios, intrauterine growth restriction.
- Any contraindications to misoprostol like those with previous allergic reaction or hypersensitivity to prostaglandin hemorrhagic disorders, and severe anemia.
- History of more than or equal 2 previous caesarean section.
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 |
|---|---|---|
| Misoprostoladministration of 100mg of misoprostol to evaluate the efficacy of Misoprostol before elective cesarean section in pregnant women with gestational age less than 38 weeks for preventing the occurrence of neonatal respiratory morbidity. | Drug | Giving no treatment before elective caesarean section., Misoprostol before elective cesarean section . |
Primary outcome
the incidence of Transient tachypnea of the newborn which defined by increase respiratory rate more than 60 cycle per minute in pregnant women with gestational age less than 38 weeks before elective cesarean section
Time frame: in the first 5 minute after delivery of fetus post operative
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 13 May 2025.
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.
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 Misoprostol in people with Misoprostol and Respiratory Distress Syndrome (RDS) of Neonate, run by Kafrelsheikh 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 13 May 2025. 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. Some participants in this study may receive a placebo. 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?
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 Merna Ashraf Ahmed farid, M.B.B.C.H (01093030236, mernaashraf2551996@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of Transient tachypnea of the newborn which defined by increase respiratory rate more than 60 cycle per minute in pregnant women with gestational age less than 38 weeks before elective cesarean section (time frame: in the first 5 minute after delivery of fetus post operative). 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 13 May 2025; AzTrials last refreshed its copy on 27 Oct 2026.