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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

NCT07774832 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-19

No results posted yet for this study

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.

Conditions

  • PROM, Preterm (Pregnancy)

Interventions

PROCEDURE

CVP-Set Amnioinfusion With McDonald Cerclage

CVP-Set Amnioinfusion With McDonald Cerclage

PROCEDURE

Conventional transabdominal amnioinfusion

Conventional transabdominal amnioinfusion was performed under sterile conditions and ultrasound guidance

Sponsors & Collaborators

  • Herlambang Herlambang

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-10
Primary Completion
2024-11-10
Completion
2024-11-10

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07774832 on ClinicalTrials.gov