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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
Sponsor: Herlambang Herlambang
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.
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2021-01-10
Completion Date
2024-11-10
Last Updated
2026-08-19
Healthy Volunteers
No
Conditions
Interventions
CVP-Set Amnioinfusion With McDonald Cerclage
CVP-Set Amnioinfusion With McDonald Cerclage
Conventional transabdominal amnioinfusion
Conventional transabdominal amnioinfusion was performed under sterile conditions and ultrasound guidance
Locations (1)
Fkik Unja Rsud Mattaher Jambi
Jambi City, Jambi, Indonesia