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

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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 - 3 Jan 2021
Event	38th Annual Meeting of the Society of Maternal Fetal Medicine - Las Vegas, United States Duration: 11 Feb 2019 → 16 Feb 2019

Bibliographical note

Presentation: Presented as a poster at the 38th Annual Meeting of the Society of Maternal Fetal Medicine, 11–16 February 2019, Las Vegas, Nevada, USA
Linked article This article is commented on by DW Skupski, p. 302 in this issue. To view this mini commentary visit https://doi.org/10.1111/1471-0528.16187.

Keywords

Follow up
infant development
neurodevelopment
oligohydramnios
second-trimester prelabour rupture of the membranes

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

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. / de Ruigh, A. A.; Simons, N. E.; van 't Hooft, J. et al.
In: BJOG: An International Journal of Obstetrics and Gynaecology, Vol. 128, No. 2, 03.01.2021, p. 292-301.

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

de Ruigh, AA, Simons, NE, van 't Hooft, J, van Teeffelen, AS, Duijnhoven, RG, van Wassenaer-Leemhuis, AG, Aarnoudse-Moens, C, van de Beek, C, Oepkes, D, Haak, MC, Woiski, M, Porath, MM, Derks, JB, van Kempen, LEM, 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

de Ruigh AA, Simons NE, van 't Hooft J, van Teeffelen AS, Duijnhoven RG, van Wassenaer-Leemhuis AG 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 3;128(2):292-301. Epub 2020 Mar 4. doi: 10.1111/1471-0528.16115

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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",

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

note = "Presentation: Presented as a poster at the 38th Annual Meeting of the Society of Maternal Fetal Medicine, 11–16 February 2019, Las Vegas, Nevada, USA Linked article This article is commented on by DW Skupski, p. 302 in this issue. To view this mini commentary visit https://doi.org/10.1111/1471-0528.16187.; 38th Annual Meeting of the Society of Maternal Fetal Medicine ; Conference date: 11-02-2019 Through 16-02-2019",

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doi = "10.1111/1471-0528.16115",

language = "English",

volume = "128",

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

T2 - 38th Annual Meeting of the Society of Maternal Fetal Medicine

AU - de Ruigh, A. A.

AU - Simons, N. E.

AU - van 't Hooft, J.

AU - van Teeffelen, A. S.

AU - Duijnhoven, R. G.

AU - van Wassenaer-Leemhuis, A. G.

AU - Aarnoudse-Moens, C.

AU - van de Beek, C.

AU - Oepkes, D.

AU - Haak, M. C.

AU - Woiski, M.

AU - Porath, M. M.

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AU - Roseboom, T. J.

AU - Mol, B. W.

AU - Pajkrt, E.

N1 - Presentation: Presented as a poster at the 38th Annual Meeting of the Society of Maternal Fetal Medicine, 11–16 February 2019, Las Vegas, Nevada, USA Linked article This article is commented on by DW Skupski, p. 302 in this issue. To view this mini commentary visit https://doi.org/10.1111/1471-0528.16187.

PY - 2021/1/3

Y1 - 2021/1/3

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.

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ER -

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

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