TY - JOUR
T1 - Childhood outcomes after induction of labor or expectant management for preterm prelabor rupture of membranes
T2 - a 10-year follow-up of the PPROMEXIL trials
AU - Simons, Noor E.
AU - de Ruigh, Annemijn A.
AU - van ’t Hooft, Janneke
AU - Aarnoudse-Moens, Cornelieke S. H.
AU - van Wely, Madelon
AU - van der Ham, David P.
AU - van Teeffelen, Augustinus S. P.
AU - Roseboom, Tessa J.
AU - Mol, Ben W.
AU - Leemhuis, Aleid G.
AU - Pajkrt, Eva
N1 - Funding Information: B.W.M. is supported by a National Health and Medical Research Council Practitioner Fellowship under grant number GNT1082548. B.W.M. further reports serving as a consultant for ObsEva, Merck, Merck KGaA, and Guerbet. The other authors report no conflict of interest. Funding Information: This study was funded by ZonMW under grant number 843002826. ZonMW peer reviewed the primary study protocol. ZonMW was not involved in the study design, data collection, analysis, and interpretation of the data, or writing of the manuscript. Funding Information: B.W.M. is supported by a National Health and Medical Research Council Practitioner Fellowship under grant number GNT1082548. B.W.M. further reports serving as a consultant for ObsEva, Merck, Merck KGaA, and Guerbet. The other authors report no conflict of interest. This study was funded by ZonMW under grant number 843002826. ZonMW peer reviewed the primary study protocol. ZonMW was not involved in the study design, data collection, analysis, and interpretation of the data, or writing of the manuscript. Publisher Copyright: © 2023 The Authors
PY - 2023/5
Y1 - 2023/5
N2 - Background: Management of late preterm prelabor rupture of membranes between 34+0 and 36+6 weeks’ gestation balances the risks of preterm birth with the risks of infection for both the mother and the neonate. Expectant management to prolong pregnancy showed similar risks of neonatal sepsis, but children at 2 years of age showed more neurodevelopmental delay when compared with induction of labor. Long-term outcomes on child development after 2 years of age are unknown. Objective: This study aimed to assess the long-term outcomes of children born after singleton pregnancies complicated by late preterm prelabor rupture of membranes managed by induction of labor in comparison with expectant management. Study Design: This was a follow-up study of the Preterm Prelabor Rupture of Membranes Expectant Management Versus Induction of Labor (PPROMEXIL) trials (randomized controlled trials between 2007 to 2011) evaluating children at 10 to 12 years of age (Netherlands Trial Register 6953). The primary outcomes were cognition, motor function, and behavior as assessed by the Wechsler Intelligence Scale for Children-V-NL, Movement Assessment Battery for Children-2, and Child Behavior Checklist, respectively. The secondary outcomes were sensory processing, respiratory problems, educational attainment, and general health. Mild delay was defined as –1 standard deviation or corresponding percentile. The relative risk and confidence intervals were calculated using standard methods. Results: This follow-up study invited 711 surviving children of the 714 singleton pregnancies randomized in the original trials. In total, 248 (35%) children participated (127 induction of labor, 121 expectant management). Children born after induction of labor had no significant differences in the primary outcomes when compared with those born after expectant management. Mild cognitive delay was observed in 7 of 122 (5.7%) children born after induction of labor in comparison with in 12 of 120 (10.0%) children born after expectant management (relative risk, 0.57; 95% confidence interval, 0.23–1.41). A mild delay in motor function was observed in 42 of 122 (34.4%) children born after induction of labor vs in 55 of 120 (45.8%) children born after expectant management (relative risk, 0.75; 95% confidence interval, 0.55–1.03). Mild abnormal behavior was observed in 37 of 125 (29.6%) children born after induction of labor compared with in 33 of 118 (28.0%) children born after expectant management (relative risk, 1.05; 95% confidence interval, 0.71–1.57). Secondary outcomes were also comparable between the induction of labor and the expectant management groups except that more children born after expectant management had a hospital admission (relative risk, 0.68; 95% confidence interval, 0.52–0.89) or a surgery (relative risk, 0.58; 95% confidence interval, 0.41–0.82). Conclusion: In children born after pregnancies with late preterm prelabor rupture of membranes, expectant management did not improve long-term outcomes at 10 to 12 years when compared with induction of labor.
AB - Background: Management of late preterm prelabor rupture of membranes between 34+0 and 36+6 weeks’ gestation balances the risks of preterm birth with the risks of infection for both the mother and the neonate. Expectant management to prolong pregnancy showed similar risks of neonatal sepsis, but children at 2 years of age showed more neurodevelopmental delay when compared with induction of labor. Long-term outcomes on child development after 2 years of age are unknown. Objective: This study aimed to assess the long-term outcomes of children born after singleton pregnancies complicated by late preterm prelabor rupture of membranes managed by induction of labor in comparison with expectant management. Study Design: This was a follow-up study of the Preterm Prelabor Rupture of Membranes Expectant Management Versus Induction of Labor (PPROMEXIL) trials (randomized controlled trials between 2007 to 2011) evaluating children at 10 to 12 years of age (Netherlands Trial Register 6953). The primary outcomes were cognition, motor function, and behavior as assessed by the Wechsler Intelligence Scale for Children-V-NL, Movement Assessment Battery for Children-2, and Child Behavior Checklist, respectively. The secondary outcomes were sensory processing, respiratory problems, educational attainment, and general health. Mild delay was defined as –1 standard deviation or corresponding percentile. The relative risk and confidence intervals were calculated using standard methods. Results: This follow-up study invited 711 surviving children of the 714 singleton pregnancies randomized in the original trials. In total, 248 (35%) children participated (127 induction of labor, 121 expectant management). Children born after induction of labor had no significant differences in the primary outcomes when compared with those born after expectant management. Mild cognitive delay was observed in 7 of 122 (5.7%) children born after induction of labor in comparison with in 12 of 120 (10.0%) children born after expectant management (relative risk, 0.57; 95% confidence interval, 0.23–1.41). A mild delay in motor function was observed in 42 of 122 (34.4%) children born after induction of labor vs in 55 of 120 (45.8%) children born after expectant management (relative risk, 0.75; 95% confidence interval, 0.55–1.03). Mild abnormal behavior was observed in 37 of 125 (29.6%) children born after induction of labor compared with in 33 of 118 (28.0%) children born after expectant management (relative risk, 1.05; 95% confidence interval, 0.71–1.57). Secondary outcomes were also comparable between the induction of labor and the expectant management groups except that more children born after expectant management had a hospital admission (relative risk, 0.68; 95% confidence interval, 0.52–0.89) or a surgery (relative risk, 0.58; 95% confidence interval, 0.41–0.82). Conclusion: In children born after pregnancies with late preterm prelabor rupture of membranes, expectant management did not improve long-term outcomes at 10 to 12 years when compared with induction of labor.
KW - PPROM
KW - childhood outcomes
KW - follow-up
KW - long-term
KW - preterm birth
KW - preterm prelabor rupture of membranes
UR - http://www.scopus.com/inward/record.url?scp=85149638678&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.ajog.2023.02.007
DO - https://doi.org/10.1016/j.ajog.2023.02.007
M3 - Article
C2 - 36787813
SN - 0002-9378
VL - 228
SP - 588.e1-588.e13
JO - American Journal of Obstetrics and Gynecology
JF - American Journal of Obstetrics and Gynecology
IS - 5
ER -