Fetal MembranesNCT01538030
Perinatal Outcome After Premature Rupture of Membranes
An observational study of Fetal Membranes and Premature Rupture, run by Saint Thomas Hospital, Panama at 1 site in Panama.
Trial summary
Premature rupture of membranes is an important cause of neonatal morbidity and mortality, mainly because of the complications associated with this pathology (oligohydramnios, cord compression or prolapse, infection). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fetal Membranes, Premature Rupture
- How many people
- 80 participants
- Where
- 1 sitePanama
- Study dates
- May 2012to Aug 2012
- 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: Pregnant patients between 24-34 weeks of gestation with a confirmed diagnosis of premature rupture of membranes.
Who may be able to join
- Gestational age between 24-34 weeks.
- Confirmed diagnosis of premature rupture of membranes.
Who cannot join
- Twin pregnancies.
- Obstetric pathologies that require immediate termination of pregnancy (severe preeclampsia, abruptio placenta, cord prolapse).
- Termination of pregnancy (whatever the reason) before complete corticoid treatment.
- Incomplete recollection of all data required for analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perinatal Outcomes According to Amniotic Fluid Indez After Premature Rupture of Membranes. A Prospective Cohort Study.
Premature rupture of membranes is an important cause of neonatal morbidity and mortality, mainly because of the complications associated with this pathology (oligohydramnios, cord compression or prolapse, infection). When rupture of the membranes occur the risk of cord compression increases but there is little evidence regarding this complication and amniotic fluid volume. The investigator's focus are the perinatal outcomes according to amniotic fluid volume (< 5 or >5).
- Conditions
- Fetal Membranes, Premature Rupture
- Keywords
- Fetal membranes, premature rupture, Cesarean section, Perinatal mortality, Neonatal sepsis, Amniotic Fluid Volume
- Medical subject headings
- Fetal Membranes, Premature Rupture, Perinatal Death, Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Amniotic Fluid Volume > 5 | Pregnant patients with gestations between 24-34 weeks with premature rupture of membranes that, when the decision was made to interrupt the pregnancy, had amniotic fluid volume index above 5.1 | |
| Amniotic Fluid Volume < 5 | Pregnant patients with gestations between 24-34 weeks with premature rupture of membranes that, when the decision was made to interrupt the pregnancy, had amniotic fluid volume index of 5 or less. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean section rate
Number of cases in each cohort that were interrupted by cesarean section due to fetal distress (evidence of cord dystocia).
Measured: 5 months
Secondary outcomes (2)
Perinatal mortality
Number of perinatal deaths (ante, peri and postpartum until 28 days postpartum)in each cohort.
Measured: 5 months
Neonatal sepsis
Number of cases of neonates diagnosed with sepsis in each cohort.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal MembranesStudies 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
- Prospective
- Enrolment
- 80 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
- NCT01538030
- Sponsor's protocol ID
- MHST2012-03
- Status last verified
- Aug 2012
- First submitted
- 18 Feb 2012
- Last updated
- 15 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perinatal Outcomes According to Amniotic Fluid Indez After Premature Rupture of Membranes. A Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT01538030
- Acronym / sponsor ID
- MHST2012-03
- Conditions
- Fetal Membranes, Premature Rupture
- Keywords
- Fetal membranes, premature rupture, Cesarean section, Perinatal mortality, Neonatal sepsis, Amniotic Fluid Volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 23 Feb 2012 (estimated)
- 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.
Premature rupture of membranes is an important cause of neonatal morbidity and mortality, mainly because of the complications associated with this pathology (oligohydramnios, cord compression or prolapse, infection). When rupture of the membranes occur the risk of cord compression increases but there is little evidence regarding this complication and amniotic fluid volume. The investigator's focus are the perinatal outcomes according to amniotic fluid volume (< 5 or >5).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amniotic Fluid Volume > 5 | – | –Pregnant patients with gestations between 24-34 weeks with premature rupture of membranes that, when the decision was made to interrupt the pregnancy, had amniotic fluid volume index above 5.1 |
| Amniotic Fluid Volume < 5 | – | –Pregnant patients with gestations between 24-34 weeks with premature rupture of membranes that, when the decision was made to interrupt the pregnancy, had amniotic fluid volume index of 5 or less. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant patients between 24-34 weeks of gestation with a confirmed diagnosis of premature rupture of membranes.
Key inclusion criteria (2 listed)
- Gestational age between 24-34 weeks.
- Confirmed diagnosis of premature rupture of membranes.
Key exclusion criteria (4 listed)
- Twin pregnancies.
- Obstetric pathologies that require immediate termination of pregnancy (severe preeclampsia, abruptio placenta, cord prolapse).
- Termination of pregnancy (whatever the reason) before complete corticoid treatment.
- Incomplete recollection of all data required for analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cesarean section rate
Time frame: 5 months
Number of cases in each cohort that were interrupted by cesarean section due to fetal distress (evidence of cord dystocia).
2 secondary outcomes
Perinatal mortality
Time frame: 5 months
Neonatal sepsis
Time frame: 5 months
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 15 Aug 2012.
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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 Fetal Membranes and Premature Rupture, 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 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: finished, as of the sponsor's last update on 15 Aug 2012. 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?
Cesarean section rate (time frame: 5 months). 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 15 Aug 2012.