OligohydramniosNCT02581774
Active Induction of Labor in Pregnancies Complicated With Oligohydramnios at Term
An observational study of Oligohydramnios, run by Sisli Hamidiye Etfal Training and Research Hospital.
Trial summary
The purpose of this study is to evaluate the risk of cesarean delivery in pregnancies complicated with isolated oligohydramnios managed by induction of labor. This prospective case-control study was conducted in Hamıdıye Sisli Etfal Teaching and Research Hospital between January 2013 and June 2014. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oligohydramnios
- What is being tested?
- normal delivery tracking
- How many people
- 324 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jun 2014
- 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 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All patients with isolated oligohydramnios were term (37-40 weeks' gestation according to accurate last menstrual period and first trimester sonographic examination). Oligohydramnios was defined as an amniotic fluid index < 5 cm. The control group consisted of prolonged pregnancies in the absence of spontaneous labor and oligohydramnios. Prolonged pregnancy is diagnosed if 41 gestational weeks are completed according to accurate date of last menstrual period and first trimester ultrasound.
Who may be able to join
- term isolated oligohydramnios
- postdate pregnancies
- vertex presentation
- singleton pregnancies
- primigravid and multigravid women
Who cannot join
- women with presence of any chronic disease
- maternal condition complicating the pregnancy
About this study
Official title: Management of Active Induction of Labor in Pregnancies Complicated With Oligohydramnios at Term; the Mode of Delivery and the Neonatal Outcomes
The purpose of this study is to evaluate the risk of cesarean delivery in pregnancies complicated with isolated oligohydramnios managed by induction of labor. This prospective case-control study was conducted in Hamıdıye Sisli Etfal Teaching and Research Hospital between January 2013 and June 2014. 159 women with isolated oligohydramnios and 165 women with postdate pregnancies who met the inclusion criteria underwent induction of labor with dinoprostone or oxytocin. The rate and the indications of C/S deliveries were compared between two groups.
Read the detailed description
The study was designed as a prospective study. The rates of cesarean section and maternal/fetal outcomes had been compared between pregnancies complicated with isolated oligohydramnios at term and postdate pregnancies. All patients with isolated oligohydramnios were term (37-40 weeks' gestation according to accurate last menstrual period and first trimester sonographic examination). Oligohydramnios was defined as an amniotic fluid index < 5 cm. The control group consisted of prolonged pregnancies in the absence of spontaneous labor and oligohydramnios. Prolonged pregnancy is diagnosed if 41 gestational weeks are completed according to accurate date of last menstrual period and first trimester ultrasound. All patients who accepted to join the study gave informed consent. All patients had a complete physical and obstetrical examination. Vital signs were recorded at regular intervals. The primary outcome measure was defined as cesarean section rates in pregnancies complicated with isolated oligohydramnios managed by induction of labor.
- Conditions
- Oligohydramnios
- Being tested
- normal delivery tracking
- Keywords
- induction, cesarean delivery
- Medical subject headings
- Oligohydramnios
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal delivery trackingOther
normal delivery tracking
| Study group | Role | What they receive |
|---|---|---|
| term isolated oligohydramnios | Labor Monitoring and normal delivery tracking Receives: Other: normal delivery tracking | |
| prolonged pregnancies | Labor Monitoring and normal delivery tracking Receives: Other: normal delivery tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean rates in pregnancies complicated with isolated oligohydramnios
Measured: up to 18 month
Secondary outcomes (3)
Fetal distress rates
Measured: up to 18 month
Number of patients (fetus) with 5-min Apgar score < 7
Measured: up to 18 month
Number of patients with meconium stained amniotic fluid
Measured: up to 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startJan 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OligohydramniosStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazlı YENIGUL, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581774
- Sponsor's protocol ID
- 304
- Status last verified
- Jan 2013
- First submitted
- 13 Oct 2015
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Active Induction of Labor in Pregnancies Complicated With Oligohydramnios at Term; the Mode of Delivery and the Neonatal Outcomes
- ClinicalTrials.gov ID
- NCT02581774
- Acronym / sponsor ID
- 304
- Conditions
- Oligohydramnios
- Keywords
- induction, cesarean delivery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 21 Oct 2015 (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.
The purpose of this study is to evaluate the risk of cesarean delivery in pregnancies complicated with isolated oligohydramnios managed by induction of labor. This prospective case-control study was conducted in Hamıdıye Sisli Etfal Teaching and Research Hospital between January 2013 and June 2014. 159 women with isolated oligohydramnios and 165 women with postdate pregnancies who met the inclusion criteria underwent induction of labor with dinoprostone or oxytocin. The rate and the indications of C/S deliveries were compared between two groups.
Detailed description
The study was designed as a prospective study. The rates of cesarean section and maternal/fetal outcomes had been compared between pregnancies complicated with isolated oligohydramnios at term and postdate pregnancies. All patients with isolated oligohydramnios were term (37-40 weeks' gestation according to accurate last menstrual period and first trimester sonographic examination). Oligohydramnios was defined as an amniotic fluid index < 5 cm. The control group consisted of prolonged pregnancies in the absence of spontaneous labor and oligohydramnios. Prolonged pregnancy is diagnosed if 41 gestational weeks are completed according to accurate date of last menstrual period and first trimester ultrasound. All patients who accepted to join the study gave informed consent. All patients had a complete physical and obstetrical examination. Vital signs were recorded at regular intervals. The primary outcome measure was defined as cesarean section rates in pregnancies complicated with isolated oligohydramnios managed by induction of labor.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| term isolated oligohydramnios | – | Other: normal delivery trackingLabor Monitoring and normal delivery tracking |
| prolonged pregnancies | – | Other: normal delivery trackingLabor Monitoring and normal delivery tracking |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All patients with isolated oligohydramnios were term (37-40 weeks' gestation according to accurate last menstrual period and first trimester sonographic examination). Oligohydramnios was defined as an amniotic fluid index < 5 cm. The control group consisted of prolonged pregnancies in the absence of spontaneous labor and oligohydramnios. Prolonged pregnancy is diagnosed if 41 gestational weeks are completed according to accurate date of last menstrual period and first trimester ultrasound.
Key inclusion criteria (5 listed)
- term isolated oligohydramnios
- postdate pregnancies
- vertex presentation
- singleton pregnancies
- primigravid and multigravid women
Key exclusion criteria (2 listed)
- women with presence of any chronic disease
- maternal condition complicating the pregnancy
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 |
|---|---|---|
| normal delivery trackingnormal delivery tracking | Other | prolonged pregnancies, term isolated oligohydramnios |
Primary outcome
Cesarean rates in pregnancies complicated with isolated oligohydramnios
Time frame: up to 18 month
3 secondary outcomes
Fetal distress rates
Time frame: up to 18 month
Number of patients (fetus) with 5-min Apgar score < 7
Time frame: up to 18 month
Number of patients with meconium stained amniotic fluid
Time frame: up to 18 month
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 21 Oct 2015.
Related trials for Oligohydramnios
RecruitingPhase 4
Effect of LMWH on Neonatal Outcomes in Isolated Oligohydramnios
Oligohydramnios, Heparin
RecruitingPhase 3
A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)
Autosomal Recessive Polycystic Kidney (ARPKD)
RecruitingObservational study
PPROM Registry (Preterm Premature Rupture of Membranes)
Fetal Membranes, Premature Rupture, Preterm Premature Rupture of the Membranes
Not yet recruiting
Impact of Enoxaparin Therapy on Fetal Outcomes in Intrauterine Growth Restriction
Intrauterine Growth Restriction
Recruiting
"Fetal gRowth AbnorMality dEtection Trial"
Small for Gestational Age Infant, Large for Gestational Age Infant
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Oligohydramnios, run by Sisli Hamidiye Etfal Training and Research Hospital.
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 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 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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 rates in pregnancies complicated with isolated oligohydramnios (time frame: up to 18 month). 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 21 Oct 2015.