Induction of Labor Affected Fetus / NewbornNCT06184139
Effect of Maternal Age and BMI on Induction of Labor Using Oral Misoprostol in Late-term Pregnancies: a Retrospective Cross-sectional Study
An observational study of Induction of Labor Affected Fetus / Newborn and Pregnancy Late, run by University of Palermo at 1 site in Italy.
Trial summary
To evaluate the effect of maternal age and body mass index (BMI) on oral misoprostol induction of labor for late-term pregnancies. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Induction of Labor Affected Fetus / Newborn, Pregnancy Late
- What is being tested?
- Misoprostol
- Type of treatment
- Pill or oral medicine
- How many people
- 104 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2023to Jan 2024
- Phase
- Observational
- 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 50 years
- Women only
- Adult
Study population: term (37 weeks or more of gestation) singleton pregnancies in women who have not had a previous cesarean delivery and a bishop score < 7.
Who may be able to join
- Late term pregnancies out of labor,
- Bishop score < 7
Who cannot join
- labor (defined as presence of at least three painful uterine contractions every ten minutes),
- uterine tachysystole (>5 contractions within 10 minutes for two consecutive 10-minute periods),
- hypertonic uterus,
- abnormal CTG,
- contraindications to vaginal delivery (fetal malpresentation such as breech presentation or transverse situation, fetal macrosomia, abnormally implanted placenta, active genital herpes infection, cervical cancer),
- patients with parity > 4,
- medical contraindication to misoprostol (asthma, glaucoma),
- women with previous hysterotomies.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Andrea Etrusco
Palermo, 90123
Andrea Etrusco, M.D.
Andrea Etrusco, M.D.
About this study
To evaluate the effect of maternal age and body mass index (BMI) on oral misoprostol induction of labor for late-term pregnancies.
- Being tested
- Misoprostol
- Keywords
- Late-term pregnancy, body mass index, age, oral misoprostol, cervical ripening, induction of labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Oral misoprostol for induction of labor in late term pregnancies
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of misoprostol for induction of labor
Efficacy induction of labor for late term pregnancies according to age and BMI
Measured: 290 days of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study startDec 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of Labor Affected Fetus / NewbornStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Etrusco, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184139
- Sponsor's protocol ID
- MISO-LATE_PREG
- Status last verified
- Dec 2023
- First submitted
- 18 Nov 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Maternal Age and BMI on Induction of Labor Using Oral Misoprostol in Late-term Pregnancies: a Retrospective Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06184139
- Acronym / sponsor ID
- MISO-LATE_PREG
- Keywords
- Late-term pregnancy, body mass index, age, oral misoprostol, cervical ripening, induction of labor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 28 Dec 2023 (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.
To evaluate the effect of maternal age and body mass index (BMI) on oral misoprostol induction of labor for late-term pregnancies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- term (37 weeks or more of gestation) singleton pregnancies in women who have not had a previous cesarean delivery and a bishop score < 7.
Key inclusion criteria (2 listed)
- Late term pregnancies out of labor,
- Bishop score < 7
Key exclusion criteria (8 listed)
- labor (defined as presence of at least three painful uterine contractions every ten minutes),
- uterine tachysystole (>5 contractions within 10 minutes for two consecutive 10-minute periods),
- hypertonic uterus,
- abnormal CTG,
- contraindications to vaginal delivery (fetal malpresentation such as breech presentation or transverse situation, fetal macrosomia, abnormally implanted placenta, active genital herpes infection, cervical cancer),
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 |
|---|---|---|
| MisoprostolOral misoprostol for induction of labor in late term pregnancies | Drug | – |
Primary outcome
Safety and tolerability of misoprostol for induction of labor
Time frame: 290 days of pregnancy
Efficacy induction of labor for late term pregnancies according to age and BMI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Induction of Labor Affected Fetus / Newborn and Pregnancy Late, run by University of Palermo at 1 site in Italy.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 28 Dec 2023. 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 Italy. 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?
Results are not available in the source record.
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?
Safety and tolerability of misoprostol for induction of labor (time frame: 290 days of pregnancy). 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 28 Dec 2023.