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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Merna Ashraf Ahmed farid, M.B.B.C.H contact

01093030236

mernaashraf2551996@gmail.com

Egypt1 site, 1 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

    Recruiting

Other trials in Egypt

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 groups in NCT06946914
Study groupRoleWhat they receive
Misoprostol before elective cesarean section .Active comparatorcandidates will receive 100mcg Misoprostol one hour before elective caesarean section.
Receives: Drug: Misoprostol
Giving no treatment before elective caesarean section.Placebo comparatorcandidates 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.

  1. 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.

  1. First posted27 Apr 2025
  2. Study start1 Jun 2024
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion1 Aug 2025 (estimated)

Resources

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)
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

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.

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