PROM, Preterm (Pregnancy)CAM-PPROMNCT07774832
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
A study testing CVP-Set Amnioinfusion With McDonald Cerclage and Conventional transabdominal amnioinfusion in people with PROM, Preterm (Pregnancy), run by Herlambang Herlambang at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- PROM, Preterm (Pregnancy)
- What is being tested?
- CVP-Set Amnioinfusion With McDonald Cerclage and Conventional transabdominal amnioinfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Jan 2021to 10 Nov 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- PROM, Preterm (Pregnancy)
- Being tested
- CVP-Set Amnioinfusion With McDonald Cerclage, Conventional transabdominal amnioinfusion
- Medical subject headings
- Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVP-Set Amnioinfusion With McDonald CerclageProcedure or surgery
CVP-Set Amnioinfusion With McDonald Cerclage
Conventional transabdominal amnioinfusionProcedure or surgery
Conventional transabdominal amnioinfusion was performed under sterile conditions and ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Conventional transabdominal amnioinfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 48 hours after amnioinfusion
maternal length of hospital stay.
Duration of maternal hospitalization associated with the amnioinfusion procedure, measured in days.
Measured: 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.
Measured: At delivery, up to approximately 34 weeks of gestation
Intrauterine fetal weight
Estimated intrauterine fetal weight before the amnioinfusion procedure, measured in grams.
Measured: Before the amnioinfusion procedure
Neonatal birth at weight
Neonatal birth weight measured immediately after delivery, expressed in grams.
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start10 Jan 2021
- Primary completion10 Nov 2024
- Study completion10 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PROM, Preterm (Pregnancy)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlambang Herlambang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Herlambang Herlambang, Universitas Jambi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774832
- Sponsor's protocol ID
- AMNIO-PPROM-001
- Acronym
- CAM-PPROM
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No