Pregnancy ComplicationsNCT03771976
Risk of Cesarean Section in Primiparous Women Over 35 Years of Age.
An observational study of Pregnancy Complications, run by Saint Thomas Hospital, Panama at 1 site in Panama.
Trial summary
The investigators reviewed Saint Thomas Maternity Hospital's database during a 5 year period and compared two cohorts of patients (primiparous women over 35 years of age and primiparous woman between 20 and 34 years of age). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy Complications
- What is being tested?
- Cesarean section and No cesarean section
- Type of treatment
- Surgery or procedure
- How many people
- 572 participants
- Where
- 1 sitePanama
- Study dates
- 1 Apr 2017to 23 Feb 2018
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primiparous women, between 22 and 42 weeks of gestation.
Who may be able to join
- Pregnant Primiparous women.
- Birth after 22 weeks and neonatal weight > 501g.
Who cannot join
- Multiparity.
- Birth before 22 weeks or neonatal weight < 500g.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk of Cesarean Section and Perinatal Complications in Primiparous Women Over 35 Years of Age. A Retrospective Cohort Study.
The investigators reviewed Saint Thomas Maternity Hospital's database during a 5 year period and compared two cohorts of patients (primiparous women over 35 years of age and primiparous woman between 20 and 34 years of age). The objective was to determine the risk of cesarean section and other perinatal complications between the groups.
- Conditions
- Pregnancy Complications
- Being tested
- Cesarean section, No cesarean section
- Keywords
- Older women (>35 years of age), Primipara, Cesarean section
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cesarean sectionProcedure or surgery
Risk of cesarean section between the cohorts
No cesarean sectionProcedure or surgery
Vaginal birth rate between the cohorts
| Study group | Role | What they receive |
|---|---|---|
| Over 35 years of age | Primiparous women over 35 years of age. Receives: Procedure: Cesarean section; Procedure: No cesarean section | |
| Between 20-34 years of age | Primiparous women between 20 and 34 years of age. Receives: Procedure: Cesarean section; Procedure: No cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of cesarean section
Rate of cesarean sections (birth by cesarean section), independent of the reason.
Measured: 5 years
Secondary outcomes (1)
Perinatal complications
Any combination of perinatal complications (Stillbirth, low apgar score) between groups.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start1 Apr 2017
- Primary completion1 Jan 2018
- Study completion23 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies 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
- 572 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Thomas Hospital, Panama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771976
- Sponsor's protocol ID
- MHST-2014-05
- Status last verified
- Dec 2018
- First submitted
- 9 Dec 2018
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual data. Just the final results.
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Cesarean Section and Perinatal Complications in Primiparous Women Over 35 Years of Age. A Retrospective Cohort Study.
- ClinicalTrials.gov ID
- NCT03771976
- Acronym / sponsor ID
- MHST-2014-05
- Conditions
- Pregnancy Complications
- Keywords
- Older women (>35 years of age), Primipara, Cesarean section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 572 participants (actual)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 23 Feb 2018 (actual)
- First posted
- 11 Dec 2018 (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 investigators reviewed Saint Thomas Maternity Hospital's database during a 5 year period and compared two cohorts of patients (primiparous women over 35 years of age and primiparous woman between 20 and 34 years of age). The objective was to determine the risk of cesarean section and other perinatal complications between the groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Over 35 years of age | – | Procedure: Cesarean section, Procedure: No cesarean sectionPrimiparous women over 35 years of age. |
| Between 20-34 years of age | – | Procedure: Cesarean section, Procedure: No cesarean sectionPrimiparous women between 20 and 34 years of age. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primiparous women, between 22 and 42 weeks of gestation.
Key inclusion criteria (2 listed)
- Pregnant Primiparous women.
- Birth after 22 weeks and neonatal weight > 501g.
Key exclusion criteria (2 listed)
- Multiparity.
- Birth before 22 weeks or neonatal weight < 500g.
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 |
|---|---|---|
| Cesarean sectionRisk of cesarean section between the cohorts | Procedure or surgery | Between 20-34 years of age, Over 35 years of age |
| No cesarean sectionVaginal birth rate between the cohorts | Procedure or surgery | Between 20-34 years of age, Over 35 years of age |
Primary outcome
Risk of cesarean section
Time frame: 5 years
Rate of cesarean sections (birth by cesarean section), independent of the reason.
1 secondary outcome
Perinatal complications
Time frame: 5 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 13 Dec 2018.
- Individual participant dataSharing planned: No. No plan to share individual data. Just the final results.
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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 Pregnancy Complications, run by Saint Thomas Hospital, Panama at 1 site in Panama.
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 2 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 13 Dec 2018. 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 Panama. 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?
Risk of cesarean section (time frame: 5 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 13 Dec 2018.