Child outcomes after amnioinfusion compared with no intervention in women with second‐trimester rupture of membranes: a long‐term follow‐up study of the PROMEXIL‐III trial

Abstract

Objective To assess the effect of transabdominal amnioinfusion or no intervention on long-term outcomes in children born after second-trimester prelabour rupture of the membranes (PROM between 16 +0/7-24 +0/7 weeks) and oligohydramnios. Population Follow up of infants of women who participated in the randomised controlled trial: PPROMEXIL-III (NTR3492). Methods Surviving infants were invited for neurodevelopmental assessment up to 5 years of corrected age using a Bayley Scales of Infant and Toddler Development or a Wechsler Preschool and Primary Scale of Intelligence. Parents were asked to complete several questionnaires. Main outcome measures Neurodevelopmental outcomes were measured. Mild delay was defined as −1 standard deviation (SD), severe delay as −2 SD. Healthy long-term survival was defined as survival without neurodevelopmental delay or respiratory problems. Results In the amnioinfusion group, 18/28 children (64%) died versus 21/28 (75%) in the no intervention group (relative risk 0.86; 95% confidence interval [CI] 0.60-1.22). Follow-up data were obtained from 14/17 (82%) children (10 amnioinfusion, 4 no intervention). In both groups, 2/28 (7.1%) had a mild neurodevelopmental delay. No severe delay was seen. Healthy longterm survival occurred in 5/28 children (17.9%) after amnioinfusion versus 2/28 (7.1%) after no intervention (odds ratio 2.50; 95% CI 0.53-11.83). When analysing data for all assessed survivors, 10/14 (71.4%) survived without mild neurodevelopmental delay and 7/14 (50%) were classified healthy long-term survivor. Conclusions In this small sample of women suffering secondtrimester PROM and oligohydramnios, amnioinfusion did not improve long-term outcomes. Overall, 71% of survivors had no neurodevelopmental delay.

Maternal, perinatal and childhood outcomes of the PPROMEXIL-III cohort: Pregnancies complicated by previable prelabor rupture of membranes

“…Normal neurodevelopment at age two and/or five was seen in 69.2% of children assessed for follow-up, and almost half reported no respiratory problems. This is comparable to the long-term outcomes of the PPROMEXIL-III trial and to other preterm birth studies [8,21,22]. Due to retrospective data collection we have no additional information about the severity of the respiratory problems.…”

“…For inclusion purposes, all women with previable PROM were prospectively registered. Methods and results of this trial are described elsewhere [7,8]. Our cohort study included all women with previable PROM during this time period in the Amsterdam region, irrespective of trial participation.…”

Perinatal and neonatal outcomes of women with very early preterm premature rupture of membranes treated via serial transabdominal amnioinfusion and expectant management: Experience of a tertiary referral center in Turkey

“…Pulmonary hypoplasia, chorioamnionitis, and orthopedic deformities are the most common short‐term morbidities after pregnancies complicated by very early PPROM, associated with increased risks of adverse neurodevelopmental outcomes caused by both premature birth and its causes. A recent study with long‐term follow‐up revealed that amnioinfusion was not associated with significant neurodevelopmental delay in children born after mid‐trimester PROM 16 . Oligohydramnios is the most important predictor of perinatal morbidity and mortality in pregnancies complicated by very early PPROM 17 .…”

“…A recent study with long-term follow-up revealed that amnioinfusion was not associated with significant neurodevelopmental delay in children born after midtrimester PROM. 16 Oligohydramnios is the most important predictor of perinatal morbidity and mortality in pregnancies complicated by very early PPROM. 17 Inverse correlations were evident between the volume of residual amniotic fluid and the prevalence of neonatal morbidities.…”

Long-term follow-up of children exposed in-utero to progesterone treatment for prevention of preterm birth: study protocol of the AMPHIA follow-up

“…As there are many questionnaires reflecting cognition and behaviour in children, and not one outcome is the most important outcome, we included a composite outcome to make a distinction for the most affected children. General health ► In a general health questionnaire, developed by our team and used in several previous follow-up studies, [32][33][34] questions will be asked on health and growth (concerning child's current and previous health, including hospital visits, medication and mental health). Health-related problems (assessed in terms of the need for medical specialist consultation and/or paramedical care, medication used in the past 12 months, hospital admissions and/ or need for surgery) will be clustered in categories to provide insight in the range of health-related problems.…”