Oligohydramnios, DeliveredNCT05559957
Isolated Oligohydramnios Less Favorable Delivery and Neonatal Outcomes
An observational study of Oligohydramnios, Delivered, run by Zagazig University at 1 site in Saudi Arabia.
Trial summary
Oligohydramnios happens in 1-5% of term pregnancies. The clinical significance of isolated oligohydramnios been a matter of debate. We aimed in this study to investigate the impact of isolated oligohydramnios on the mode of delivery and risk of adverse perinatal outcome. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oligohydramnios, Delivered
- What is being tested?
- observation of delivery and neonatal outcomes
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 636 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2020to 1 May 2022
- How long will I take part?
- 3 Months
- 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
- Healthy volunteers accepted
- Adult
Study population: Pregnant women between 32 and 41 weeks with otherwise normal pregnancy. Isolated oligohydramnios group are diagnosed with amniotic fluid index less than 5.
Who may be able to join
- Third trimester pregnancy
- Isolated oligohydramnios
Who cannot join
- Multiple pregnancy
- less than 32 weeks
- medical disorders like DM HPN
- Fetal jeopardy
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Armed Forces Hospitals Southern Region
Khamis Mushait, 62411
About this study
Official title: Isolated Oligohydramnios is Associated With Less Favorable Delivery and Composite Neonatal Outcomes
Oligohydramnios happens in 1-5% of term pregnancies. The clinical significance of isolated oligohydramnios been a matter of debate. We aimed in this study to investigate the impact of isolated oligohydramnios on the mode of delivery and risk of adverse perinatal outcome.
Read the detailed description
Retrospective study conducted in Armed Forces Hospitals of Southern Region, comparing cases with oligohydramnios (amniotic fluid level index <5) to normal amniotic fluid cases (amniotic fluid level index ≥ 8). Primary outcomes are the mode of delivery and adverse perinatal outcomes (including mortality, NICU admission, low Apgar score and sepsis)
- Conditions
- Oligohydramnios, Delivered
- Being tested
- observation of delivery and neonatal outcomes
- Medical subject headings
- Oligohydramnios
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation of delivery and neonatal outcomesBehavioural
MONITORING THE DELIVERY MODE EITHER CESAREAN OR VAGINAL, BESIDE THE NEONATAL OUTCOME AND MORBIDITIES IN BOTH GROUPS
| Study group | Role | What they receive |
|---|---|---|
| Isolated oligohydramnios group | Cases with oligohydramnios (amniotic fluid index less than 5) without an overt underlying reason in the third trimester Receives: Behavioral: observation of delivery and neonatal outcomes | |
| Normal amniotic fluid group | Normal pregnancy cases with normal amniotic fluid index Receives: Behavioral: observation of delivery and neonatal outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery mode
Either vaginal delivery or cesarean section
Measured: through study completion, an average of 1 year
Composite neonatal outcomes
Risk of low Apgar score, transient tachypnea of newborn, ICU admission, etc
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Induction of labor rate
Comparing incidence of labor induction between both groups and between gestational age groups
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start1 Jan 2020
- Primary completion1 Mar 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oligohydramnios, DeliveredStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 636 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hytham Atia, Zagazig University
- Investigators
- Hytham Atia Atia, M.D., Principal investigator, Armed Forces Hospitals Southern Region KSA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559957
- Sponsor's protocol ID
- AFHSRMREC/2020/OB/GYNAE/429
- Status last verified
- Sep 2022
- First submitted
- 26 Sep 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhang J, Troendle J, Meikle S, Klebanoff MA, Rayburn WF. Isolated oligohydramnios is not associated with adverse perinatal outcomes. BJOG. 2004 Mar;111(3):220-5. doi: 10.1111/j.1471-0528.2004.00060.x.
PubMed 14961882
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolated Oligohydramnios is Associated With Less Favorable Delivery and Composite Neonatal Outcomes
- ClinicalTrials.gov ID
- NCT05559957
- Acronym / sponsor ID
- AFHSRMREC/2020/OB/GYNAE/429
- Conditions
- Oligohydramnios, Delivered
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 636 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 29 Sep 2022 (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.
Oligohydramnios happens in 1-5% of term pregnancies. The clinical significance of isolated oligohydramnios been a matter of debate. We aimed in this study to investigate the impact of isolated oligohydramnios on the mode of delivery and risk of adverse perinatal outcome.
Detailed description
Retrospective study conducted in Armed Forces Hospitals of Southern Region, comparing cases with oligohydramnios (amniotic fluid level index <5) to normal amniotic fluid cases (amniotic fluid level index ≥ 8). Primary outcomes are the mode of delivery and adverse perinatal outcomes (including mortality, NICU admission, low Apgar score and sepsis)
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isolated oligohydramnios group | – | Behavioral: observation of delivery and neonatal outcomesCases with oligohydramnios (amniotic fluid index less than 5) without an overt underlying reason in the third trimester |
| Normal amniotic fluid group | – | Behavioral: observation of delivery and neonatal outcomesNormal pregnancy cases with normal amniotic fluid index |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women between 32 and 41 weeks with otherwise normal pregnancy. Isolated oligohydramnios group are diagnosed with amniotic fluid index less than 5.
Key inclusion criteria (2 listed)
- Third trimester pregnancy
- Isolated oligohydramnios
Key exclusion criteria (4 listed)
- Multiple pregnancy
- less than 32 weeks
- medical disorders like DM HPN
- Fetal jeopardy
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 |
|---|---|---|
| observation of delivery and neonatal outcomesMONITORING THE DELIVERY MODE EITHER CESAREAN OR VAGINAL, BESIDE THE NEONATAL OUTCOME AND MORBIDITIES IN BOTH GROUPS | Behavioural | Isolated oligohydramnios group, Normal amniotic fluid group |
Primary outcome
Delivery mode
Time frame: through study completion, an average of 1 year
Either vaginal delivery or cesarean section
Composite neonatal outcomes
Time frame: through study completion, an average of 1 year
Risk of low Apgar score, transient tachypnea of newborn, ICU admission, etc
1 secondary outcome
Induction of labor rate
Time frame: through study completion, an average of 1 year
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 30 Sep 2022.
- Background: PubMed 14961882Zhang J, Troendle J, Meikle S, Klebanoff MA, Rayburn WF. Isolated oligohydramnios is not associated with adverse perinatal outcomes. BJOG. 2004 Mar;111(3):220-5. doi: 10.1111/j.1471-0528.2004.00060.x.
- Individual participant dataSharing planned: Undecided
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.
Hytham Atia Atia, M.D. principal investigator
Armed Forces Hospitals Southern Region KSA
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 Oligohydramnios, Delivered, run by Zagazig University at 1 site in Saudi Arabia.
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 30 Sep 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 Saudi Arabia. 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?
Delivery mode (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05559957, which also lists 1 linked publication.
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 30 Sep 2022.