Low Risk PregnancyNCT04412915
Correlation Between Early Induction of Labor and Cesarean Delivery in Low-risk Nulliparous Women
An observational study of Low Risk Pregnancy, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
To elucidate whether induction of labor in primiparas with low-risk pregnancies at 38 + 0 to 40 + 6 gestational weeks will increase the cesarean rate, compared with those receiving labor induction at more than 41+0 gestational weeks. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Low Risk Pregnancy
- What is being tested?
- Labor induction
- How many people
- 2,125 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 May 2020to 23 Aug 2021
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Medical records of all consecutive primiparas with low-risk pregnancy from January 1, 2014 to August 31, 2019
Who may be able to join
- After 38 + 0 weeks of gestation
- low-risk pregnant primiparas
- singleton
- nulliparous
- > 20 years old
Who cannot join
- Premature rupture of membranes
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
Banqiao District, New Taipei, 22050
About this study
To elucidate whether induction of labor in primiparas with low-risk pregnancies at 38 + 0 to 40 + 6 gestational weeks will increase the cesarean rate, compared with those receiving labor induction at more than 41+0 gestational weeks.
Read the detailed description
Medical records of all consecutive primiparas with low-risk pregnancy from January 1, 2014 to August 31, 2019 were reviewed to explore the correlation between early induction of labor and caesarean birth after 38 + 0 weeks. The hypothesis of the study is that induction of labor in primiparas with low-risk pregnancies at 38 + 0 to 40 + 6 gestational weeks will increase the cesarean rate, compared with those receiving labor induction at more than 41+0 gestational weeks.
- Conditions
- Low Risk Pregnancy
- Being tested
- Labor induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labor inductionOther
Labor induction with oxytocin or prostagladin
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean rate rate
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start21 May 2020
- Primary completion4 Jun 2021
- Study completion23 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Risk PregnancyStudies 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
- 2,125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412915
- Sponsor's protocol ID
- 109050-F
- Status last verified
- Dec 2021
- First submitted
- 31 May 2020
- Last updated
- 8 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Early Induction of Labor and Cesarean Delivery in Low-risk Nulliparous Women
- ClinicalTrials.gov ID
- NCT04412915
- Acronym / sponsor ID
- 109050-F
- Conditions
- Low Risk Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,125 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 21 May 2020 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 23 Aug 2021 (actual)
- First posted
- 2 Jun 2020 (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 elucidate whether induction of labor in primiparas with low-risk pregnancies at 38 + 0 to 40 + 6 gestational weeks will increase the cesarean rate, compared with those receiving labor induction at more than 41+0 gestational weeks.
Detailed description
Medical records of all consecutive primiparas with low-risk pregnancy from January 1, 2014 to August 31, 2019 were reviewed to explore the correlation between early induction of labor and caesarean birth after 38 + 0 weeks. The hypothesis of the study is that induction of labor in primiparas with low-risk pregnancies at 38 + 0 to 40 + 6 gestational weeks will increase the cesarean rate, compared with those receiving labor induction at more than 41+0 gestational weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Medical records of all consecutive primiparas with low-risk pregnancy from January 1, 2014 to August 31, 2019
Key inclusion criteria (5 listed)
- After 38 + 0 weeks of gestation
- low-risk pregnant primiparas
- singleton
- nulliparous
- > 20 years old
Key exclusion criteria (1 listed)
- Premature rupture of membranes
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 |
|---|---|---|
| Labor inductionLabor induction with oxytocin or prostagladin | Other | – |
Primary outcome
Cesarean rate rate
Time frame: 10 years
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 8 Feb 2022.
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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 Low Risk Pregnancy, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 1 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 8 Feb 2022. 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 Taiwan. 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?
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?
Cesarean rate rate (time frame: 10 years). 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 8 Feb 2022; AzTrials last refreshed its copy on 6 Nov 2026.