Can a CVP set restore amniotic fluid and improve newborn health?
NCT ID NCT07774832
First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time
Summary
This trial compares two methods of amnioinfusion—adding fluid to the womb—in pregnant women with preterm premature rupture of membranes (PPROM) and very low amniotic fluid. One method uses a central venous pressure (CVP) set for controlled fluid delivery, while the other uses the standard transabdominal approach. The study aims to see if the CVP-set method better restores amniotic fluid levels and improves outcomes like birth weight and Apgar scores. Forty women with PPROM at 24-26 weeks of pregnancy will be enrolled and followed through delivery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CVP-set amnioinfusion with McDonald cerclage
- What this could lead to
- If effective, this technique could offer a safer, more controlled way to restore amniotic fluid in PPROM, potentially improving pregnancy and newborn outcomes.
- What could go wrong
- This is a small, non-randomized study, so results may not be conclusive. The procedure carries risks of infection or complications, and benefits over conventional amnioinfusion are not yet proven.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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40 people
The number who actually took part.
- Started
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Jan 2021
- Finished
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Nov 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Singleton pregnancy. * Preterm premature rupture of membranes (PPROM) at 24-26 weeks of gestation. * Oligohydramnios with an amniotic fluid index (AFI) \<2 cm. * Provided informed consent to participate in the study. Exclusion Criteria: * Presence of uterine contractions. * Clinical or laboratory signs of intrauterine infection. * Pregnancy complications requiring immediate termination of pregnancy, including hypertension, preeclampsia, HELLP syndrome, or other significant maternal conditions.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fkik Unja Rsud Mattaher Jambi
Jambi City, Jambi, 36361, Indonesia
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