Fkik Unja Rsud Mattaher Jambi
Jambi City, Jambi, 36361, Indonesia
NCT Number: NCT07774832
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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Jambi City, Jambi, 36361, Indonesia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CVP-Set Amnioinfusion With McDonald Cerclage
Conventional transabdominal amnioinfusion was performed under sterile conditions and ultrasound guidance
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.
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.
Time frame: At delivery, up to approximately 34 weeks of gestation
Gestational age at the time of delivery, measured in weeks of gestation.
Time frame: Before the amnioinfusion procedure
Estimated intrauterine fetal weight before the amnioinfusion procedure, measured in grams.
Time frame: At birth
Neonatal birth weight measured immediately after delivery, expressed in grams.
Herlambang Herlambang
Other
Acronym: CAM-PPROM
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