An interventional study of CVP-Set Amnioinfusion With McDonald Cerclage and Conventional transabdominal amnioinfusion in PROM, Preterm (Pregnancy), sponsored by Herlambang Herlambang. Completed at 1 site in Indonesia. Open to female participants. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Herlambang Herlambang · Not applicable, Interventional, and Treatment
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This prospective, two-arm, non-randomized comparative interventional study evaluated the effectiveness of amnioinfusion using a central venous pressure (CVP) set compared with conventional transabdominal amnioinfusion in pregnant women with preterm premature rupture of membranes (PPROM) complicated by severe oligohydramnios.
A total of 40 pregnant women with singleton pregnancies, PPROM at 24-26 weeks of gestation, and an amniotic fluid index (AFI) of less than 2 cm were enrolled. Participants were allocated to either the CVP-set amnioinfusion group or the conventional transabdominal amnioinfusion group according to procedural feasibility and operator availability. Both groups underwent amnioinfusion followed by cervical cerclage.
In the conventional group, amnioinfusion was performed transabdominally under ultrasound guidance. In the intervention group, a CVP set was used to allow controlled and sustained intra-amniotic fluid administration through a single access site. Maternal and fetal conditions were monitored during and after the procedure, and participants were followed with repeated clinical and ultrasonographic assessments.
The primary outcome was the change in AFI following the intervention. Secondary outcomes included gestational age at delivery, neonatal birth weight, Apgar scores, maternal length of hospital stay, and procedural outcomes. The study aimed to determine whether CVP-set amnioinfusion could provide better restoration and maintenance of amniotic fluid volume and improve pregnancy and neonatal outcomes compared with conventional transabdominal amnioinfusion.
This study was conducted to evaluate a novel approach to amnioinfusion in pregnant women with preterm premature rupture of membranes (PPROM) complicated by severe oligohydramnios. The intervention used a central venous pressure (CVP) set to provide controlled and sustained transabdominal amnioinfusion through a single access site, with the aim of restoring and maintaining amniotic fluid volume while reducing the need for repeated puncture.
The study used a prospective, two-arm, non-randomized comparative interventional design. A total of 40 pregnant women with singleton pregnancies, PPROM between 24 and 26 weeks of gestation, and an amniotic fluid index (AFI) of less than 2 cm were enrolled. Participants were allocated to either the CVP-set amnioinfusion group or the conventional transabdominal amnioinfusion group according to procedural feasibility and operator availability. Both groups underwent amnioinfusion followed by cervical cerclage.
In the conventional amnioinfusion group, the procedure was performed transabdominally under sterile conditions and ultrasound guidance. In the intervention group, a CVP set was inserted into the intra-amniotic cavity to permit controlled and sustained infusion. Maternal condition, uterine activity, fetal well-being, and amniotic fluid volume were monitored during and after the procedure. Participants were subsequently followed with serial clinical and ultrasonographic assessments.
The primary outcome was the increase in AFI following the intervention. Secondary outcomes included gestational age at delivery, neonatal birth weight, Apgar scores, maternal length of hospital stay, procedural feasibility, maternal tolerance, and complications. The study was designed to determine whether CVP-set amnioinfusion could improve restoration and maintenance of amniotic fluid volume and pregnancy and neonatal outcomes compared with conventional transabdominal amnioinfusion.
100 studies on the registry are indexed under Fetal Membranes, Premature Rupture; 23 are open to participants now.
This study's enrollment of 40 is below the median of 150 across 59 interventional studies indexed under Fetal Membranes, Premature Rupture.
Browse Fetal Membranes, Premature Rupture studies →This is the only study on the registry with Herlambang Herlambang as lead sponsor.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received transabdominal amnioinfusion using a central venous pressure (CVP) set under ultrasound guidance. The CVP set was maintained to allow controlled and sustained intra-amniotic fluid administration through a single access site. Cervical cerclage was performed following the amnioinfusion procedure.
Procedure: CVP-Set Amnioinfusion With McDonald Cerclage
Participants received conventional transabdominal amnioinfusion under sterile conditions and ultrasound guidance, followed by cervical cerclage. This arm served as the active comparator for evaluating the effectiveness of CVP-set amnioinfusion.
Procedure: Conventional transabdominal amnioinfusion
CVP-Set Amnioinfusion With McDonald Cerclage
Conventional transabdominal amnioinfusion was performed under sterile conditions and ultrasound guidance
Change in Amniotic Fluid Index (AFI)
Change in amniotic fluid index (AFI), measured in centimeters by ultrasonography, from baseline before amnioinfusion to the post-intervention assessment. The change in AFI was compared between the CVP-set amnioinfusion and conventional transabdominal amnioinfusion groups.
Time frame: Baseline to 48 hours after amnioinfusion
maternal length of hospital stay.
Duration of maternal hospitalization associated with the amnioinfusion procedure, measured in days.
Time frame: From the amnioinfusion procedure until hospital discharge, up to 5 days
Gestational Age at Delivery
Gestational age at the time of delivery, measured in weeks of gestation.
Time frame: At delivery, up to approximately 34 weeks of gestation
Intrauterine fetal weight
Estimated intrauterine fetal weight before the amnioinfusion procedure, measured in grams.
Time frame: Before the amnioinfusion procedure
Neonatal birth at weight
Neonatal birth weight measured immediately after delivery, expressed in grams.
Time frame: At birth
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2021 to primary completion in Nov 2024, 46 months.
Of 23 interventional studies with no phase under Fetal Membranes, Premature Rupture, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 62. This study's 46 months is above that.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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