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Novel Use of Central Venous Pressure (CVP) Set With McDonald Cerclage Technique for Amnioinfusion in Preterm Premature Rupture of Membranes Improves Amniotic Fluid Index and Neonatal Outcomes

Novel Use of Central Venous Pressure (CVP) Set With McDonald Cerclage Technique for Amnioinfusion in Preterm Premature Rupture of Membranes Improves Amniotic Fluid Index and Neonatal Outcomes

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07774832
Acronym
CAM-PPROM
Enrollment
40
Registered
2026-08-19
Start date
2021-01-10
Completion date
2024-11-10
Last updated
2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PROM, Preterm (Pregnancy)

Brief summary

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.

Detailed description

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.

Interventions

PROCEDURECVP-Set Amnioinfusion With McDonald Cerclage

CVP-Set Amnioinfusion With McDonald Cerclage

PROCEDUREConventional transabdominal amnioinfusion

Conventional transabdominal amnioinfusion was performed under sterile conditions and ultrasound guidance

Sponsors

Herlambang Herlambang
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Amniotic Fluid Index (AFI)Baseline to 48 hours after amnioinfusionChange 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.
maternal length of hospital stay.From the amnioinfusion procedure until hospital discharge, up to 5 daysDuration of maternal hospitalization associated with the amnioinfusion procedure, measured in days.
Gestational Age at DeliveryAt delivery, up to approximately 34 weeks of gestationGestational age at the time of delivery, measured in weeks of gestation.
Intrauterine fetal weightBefore the amnioinfusion procedureEstimated intrauterine fetal weight before the amnioinfusion procedure, measured in grams.
Neonatal birth at weightAt birthNeonatal birth weight measured immediately after delivery, expressed in grams.

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026