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 | Completed

• 1 other identifier: AMNIO-PPROM-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

PROM, Preterm (Pregnancy)

Outcome Measures

Primary Outcomes (5)

• 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.

  Baseline to 48 hours after amnioinfusion

• maternal length of hospital stay.

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

  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.

  At delivery, up to approximately 34 weeks of gestation

• Intrauterine fetal weight

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

  Before the amnioinfusion procedure

• Neonatal birth at weight

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

  At birth

Study Arms (2)

CVP-Set Amnioinfusion

EXPERIMENTAL

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

Conventional Transabdominal Amnioinfusion

ACTIVE COMPARATOR

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

Interventions

CVP-Set Amnioinfusion With McDonald Cerclage PROCEDURE

CVP-Set Amnioinfusion With McDonald Cerclage

CVP-Set Amnioinfusion

Conventional transabdominal amnioinfusion PROCEDURE

Conventional transabdominal amnioinfusion was performed under sterile conditions and ultrasound guidance

Conventional Transabdominal Amnioinfusion

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Herlambang Herlambang: lead

Study Sites (1)

Fkik Unja Rsud Mattaher Jambi

Jambi City, Jambi, 36361, Indonesia

Location

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 19, 2026
• Study Start: January 10, 2021
• Primary Completion: November 10, 2024
• Study Completion: November 10, 2024
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)