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

A. A. de Ruigh; N. E. Simons; J. van't Hooft; A. S. van Teeffelen; R. G. Duijnhoven; A. G. van Wassenaer-Leemhuis; C. Aarnoudse-Moens; C. van de Beek; D. Oepkes; M. C. Haak; M. Woiski; M. M. Porath; J. B. Derks; L. E. M. van Kempen; T. J. Roseboom; B. W. Mol; E. Pajkrt

doi:10.1111/1471-0528.16115

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

A. A. de Ruigh^*, N. E. Simons, J. van't Hooft, A. S. van Teeffelen, R. G. Duijnhoven, A. G. van Wassenaer-Leemhuis, C. Aarnoudse-Moens, C. van de Beek, D. Oepkes, M. C. Haak, M. Woiski, M. M. Porath, J. B. Derks, L. E. M. van Kempen, T. J. Roseboom, B. W. Mol, E. Pajkrt

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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 long-term 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 second-trimester PROM and oligohydramnios, amnioinfusion did not improve long-term outcomes. Overall, 71% of survivors had no neurodevelopmental delay.

Tweetable abstract Healthy long-term survival was comparable for children born after second-trimester PROM and treatment with amnioinfusion or no intervention.

Original language	English
Pages (from-to)	292-301
Number of pages	10
Journal	Bjog-an International Journal of Obstetrics and Gynaecology
Volume	128
Issue number	2
Early online date	4 Mar 2020
DOIs	https://doi.org/10.1111/1471-0528.16115
Publication status	Published - Jan 2021

Keywords

Follow up
infant development
neurodevelopment
oligohydramnios
second-trimester prelabour rupture of the membranes
PRETERM PREMATURE RUPTURE
EXPECTANT MANAGEMENT
PRELABOR RUPTURE
PREGNANCY
OLIGOHYDRAMNIOS
AMIPROM

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Cite this

Ruigh, A. A. D., Simons, N. E., Hooft, J. V., Teeffelen, A. S. V., Duijnhoven, R. G., Wassenaer-Leemhuis, A. G. V., Aarnoudse-Moens, C., Beek, C. V. D., Oepkes, D., Haak, M. C., Woiski, M., Porath, M. M., Derks, J. B., Kempen, L. E. M. V., Roseboom, T. J., Mol, B. W., & Pajkrt, E. (2021). 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. Bjog-an International Journal of Obstetrics and Gynaecology, 128(2), 292-301. https://doi.org/10.1111/1471-0528.16115

@article{c8400239243c4054821e388c9ced0347,

title = "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 long-term 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 second-trimester PROM and oligohydramnios, amnioinfusion did not improve long-term outcomes. Overall, 71% of survivors had no neurodevelopmental delay.Tweetable abstract Healthy long-term survival was comparable for children born after second-trimester PROM and treatment with amnioinfusion or no intervention.",

keywords = "Follow up, infant development, neurodevelopment, oligohydramnios, second-trimester prelabour rupture of the membranes, PRETERM PREMATURE RUPTURE, EXPECTANT MANAGEMENT, PRELABOR RUPTURE, PREGNANCY, OLIGOHYDRAMNIOS, AMIPROM",

author = "Ruigh, {A. A. de} and Simons, {N. E.} and Hooft, {J. van't} and Teeffelen, {A. S. van} and Duijnhoven, {R. G.} and Wassenaer-Leemhuis, {A. G. van} and C. Aarnoudse-Moens and Beek, {C. van de} and D. Oepkes and Haak, {M. C.} and M. Woiski and Porath, {M. M.} and Derks, {J. B.} and Kempen, {L. E. M. van} and Roseboom, {T. J.} and Mol, {B. W.} and E. Pajkrt",

note = "Funding Information: Dr Ben Willem Mol is supported by an NHMRC Practitioner Fellowship (GNT1082548). Dr Ben Willem Mol reports consultancy for ObsEva, Merck KGaA, and Guerbet. The other authors have not reported any potential conflicts of interest. Completed disclosure of interest forms are available to view online as supporting information. Publisher Copyright: {\textcopyright} 2020 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists",

year = "2021",

month = jan,

doi = "10.1111/1471-0528.16115",

language = "English",

volume = "128",

pages = "292--301",

journal = "Bjog-an International Journal of Obstetrics and Gynaecology",

issn = "1470-0328",

publisher = "Wiley",

number = "2",

}

Ruigh, AAD, Simons, NE, Hooft, JV, Teeffelen, ASV, Duijnhoven, RG, Wassenaer-Leemhuis, AGV, Aarnoudse-Moens, C, Beek, CVD, Oepkes, D, Haak, MC, Woiski, M, Porath, MM, Derks, JB, Kempen, LEMV, Roseboom, TJ, Mol, BW & Pajkrt, E 2021, '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', Bjog-an International Journal of Obstetrics and Gynaecology, vol. 128, no. 2, pp. 292-301. https://doi.org/10.1111/1471-0528.16115

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. / Ruigh, A. A. de; Simons, N. E.; Hooft, J. van't et al.
In: Bjog-an International Journal of Obstetrics and Gynaecology, Vol. 128, No. 2, 01.2021, p. 292-301.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Child outcomes after amnioinfusion compared with no intervention in women with second-trimester rupture of membranes

T2 - a long-term follow-up study of the PROMEXIL-III trial

AU - Ruigh, A. A. de

AU - Simons, N. E.

AU - Hooft, J. van't

AU - Teeffelen, A. S. van

AU - Duijnhoven, R. G.

AU - Wassenaer-Leemhuis, A. G. van

AU - Aarnoudse-Moens, C.

AU - Beek, C. van de

AU - Oepkes, D.

AU - Haak, M. C.

AU - Woiski, M.

AU - Porath, M. M.

AU - Derks, J. B.

AU - Kempen, L. E. M. van

AU - Roseboom, T. J.

AU - Mol, B. W.

AU - Pajkrt, E.

N1 - Funding Information: Dr Ben Willem Mol is supported by an NHMRC Practitioner Fellowship (GNT1082548). Dr Ben Willem Mol reports consultancy for ObsEva, Merck KGaA, and Guerbet. The other authors have not reported any potential conflicts of interest. Completed disclosure of interest forms are available to view online as supporting information. Publisher Copyright: © 2020 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists

PY - 2021/1

Y1 - 2021/1

N2 - 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 long-term 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 second-trimester PROM and oligohydramnios, amnioinfusion did not improve long-term outcomes. Overall, 71% of survivors had no neurodevelopmental delay.Tweetable abstract Healthy long-term survival was comparable for children born after second-trimester PROM and treatment with amnioinfusion or no intervention.

AB - 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 long-term 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 second-trimester PROM and oligohydramnios, amnioinfusion did not improve long-term outcomes. Overall, 71% of survivors had no neurodevelopmental delay.Tweetable abstract Healthy long-term survival was comparable for children born after second-trimester PROM and treatment with amnioinfusion or no intervention.

KW - Follow up

KW - infant development

KW - neurodevelopment

KW - oligohydramnios

KW - second-trimester prelabour rupture of the membranes

KW - PRETERM PREMATURE RUPTURE

KW - EXPECTANT MANAGEMENT

KW - PRELABOR RUPTURE

KW - PREGNANCY

KW - OLIGOHYDRAMNIOS

KW - AMIPROM

U2 - 10.1111/1471-0528.16115

DO - 10.1111/1471-0528.16115

M3 - Article

C2 - 31984652

SN - 1470-0328

VL - 128

SP - 292

EP - 301

JO - Bjog-an International Journal of Obstetrics and Gynaecology

JF - Bjog-an International Journal of Obstetrics and Gynaecology

IS - 2

ER -

Ruigh AAD, Simons NE, Hooft JV, Teeffelen ASV, Duijnhoven RG, Wassenaer-Leemhuis AGV et al. 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. Bjog-an International Journal of Obstetrics and Gynaecology. 2021 Jan;128(2):292-301. Epub 2020 Mar 4. doi: 10.1111/1471-0528.16115