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Completed

NCT Number: NCT07774832

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

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fkik Unja Rsud Mattaher Jambi

Jambi City, Jambi, 36361, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CVP-Set Amnioinfusion With McDonald Cerclage

Procedure

CVP-Set Amnioinfusion With McDonald Cerclage

Conventional transabdominal amnioinfusion

Procedure

Conventional transabdominal amnioinfusion was performed under sterile conditions and ultrasound guidance

Primary outcomes

  1. Change in Amniotic Fluid Index (AFI)

    Time frame: Baseline to 48 hours after amnioinfusion

    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.

  2. maternal length of hospital stay.

    Time frame: From the amnioinfusion procedure until hospital discharge, up to 5 days

    Duration of maternal hospitalization associated with the amnioinfusion procedure, measured in days.

  3. Gestational Age at Delivery

    Time frame: At delivery, up to approximately 34 weeks of gestation

    Gestational age at the time of delivery, measured in weeks of gestation.

  4. Intrauterine fetal weight

    Time frame: Before the amnioinfusion procedure

    Estimated intrauterine fetal weight before the amnioinfusion procedure, measured in grams.

  5. Neonatal birth at weight

    Time frame: At birth

    Neonatal birth weight measured immediately after delivery, expressed in grams.

Sponsors and collaborators

Lead sponsor

Herlambang Herlambang

Other

Registry information

Acronym: CAM-PPROM

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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