Amnioinfusion Compared With No Intervention in Women With Second-Trimester Rupture of Membranes: A Randomized Controlled Trial

Liselotte E.M. van Kempen, Augustinus S. van Teeffelen, Annemijn A. de Ruigh, Dick Oepkes, Monique C. Haak, Elisabeth van Leeuwen, Mallory Woiski, Martina M. Porath, Caroline J. Bax, Aleid G. van Wassenaer-Leemhuis, Antonius L. Mulder, David P. van der Ham, Christine Willekes, Maureen T. Franssen, Jan B. Derks, Ewoud Schuit, Ben W. Mol, Eva Pajkrt

Research output: Contribution to journalArticleResearchpeer-review

Abstract

OBJECTIVE: To assess the effectiveness of amnioinfusion in women with second-trimester preterm prelabor rupture of membranes. METHODS: We performed a nationwide, multicenter, open-label, randomized controlled trial, the PPROM: Expectant Management versus Induction of Labor-III (PPROMEXIL-III) trial, in women with singleton pregnancies and preterm prelabor rupture of membranes at 16 0/7 to 24 0/7 weeks of gestation with oligohydramnios (single deepest pocket less than 20 mm). Participants were allocated to transabdominal amnioinfusion or no intervention in a one-to-one ratio by a web-based system. If the single deepest pocket was less than 20 mm on follow-up visits, amnioinfusion was repeated weekly until 28 0/7 weeks of gestation. The primary outcome was perinatal mortality. We needed 56 women to show a reduction in perinatal mortality from 70% to 35% (β error 0.20, two-sided α error 0.05). RESULTS: Between June 15, 2012, and January 13, 2016, we randomized 28 women to amnioinfusion and 28 to no intervention. One woman was enrolled before the trial registration date (June 19, 2012). Perinatal mortality rates were 18 of 28 (64%) in the amnioinfusion group vs 21 of 28 (75%) in the no intervention group (relative risk 0.86, 95% CI 0.60-1.22, P=.39). CONCLUSION: In women with second-trimester preterm prelabor rupture of membranes and oligohydramnios, we found no reduction in perinatal mortality after amnioinfusion. CLINICAL TRIAL REGISTRATION: NTR Dutch Trial Register, NTR3492.

LanguageEnglish
Pages129-136
Number of pages8
JournalObstetrics and Gynecology
Volume133
Issue number1
DOIs
Publication statusPublished - 1 Jan 2019
Externally publishedYes

Cite this

van Kempen, L. E. M., van Teeffelen, A. S., de Ruigh, A. A., Oepkes, D., Haak, M. C., van Leeuwen, E., ... Pajkrt, E. (2019). Amnioinfusion Compared With No Intervention in Women With Second-Trimester Rupture of Membranes: A Randomized Controlled Trial. Obstetrics and Gynecology, 133(1), 129-136. https://doi.org/10.1097/AOG.0000000000003003
van Kempen, Liselotte E.M. ; van Teeffelen, Augustinus S. ; de Ruigh, Annemijn A. ; Oepkes, Dick ; Haak, Monique C. ; van Leeuwen, Elisabeth ; Woiski, Mallory ; Porath, Martina M. ; Bax, Caroline J. ; van Wassenaer-Leemhuis, Aleid G. ; Mulder, Antonius L. ; van der Ham, David P. ; Willekes, Christine ; Franssen, Maureen T. ; Derks, Jan B. ; Schuit, Ewoud ; Mol, Ben W. ; Pajkrt, Eva. / Amnioinfusion Compared With No Intervention in Women With Second-Trimester Rupture of Membranes : A Randomized Controlled Trial. In: Obstetrics and Gynecology. 2019 ; Vol. 133, No. 1. pp. 129-136.
@article{b3c97074e2b44b049bc20c9d8c29ae16,
title = "Amnioinfusion Compared With No Intervention in Women With Second-Trimester Rupture of Membranes: A Randomized Controlled Trial",
abstract = "OBJECTIVE: To assess the effectiveness of amnioinfusion in women with second-trimester preterm prelabor rupture of membranes. METHODS: We performed a nationwide, multicenter, open-label, randomized controlled trial, the PPROM: Expectant Management versus Induction of Labor-III (PPROMEXIL-III) trial, in women with singleton pregnancies and preterm prelabor rupture of membranes at 16 0/7 to 24 0/7 weeks of gestation with oligohydramnios (single deepest pocket less than 20 mm). Participants were allocated to transabdominal amnioinfusion or no intervention in a one-to-one ratio by a web-based system. If the single deepest pocket was less than 20 mm on follow-up visits, amnioinfusion was repeated weekly until 28 0/7 weeks of gestation. The primary outcome was perinatal mortality. We needed 56 women to show a reduction in perinatal mortality from 70{\%} to 35{\%} (β error 0.20, two-sided α error 0.05). RESULTS: Between June 15, 2012, and January 13, 2016, we randomized 28 women to amnioinfusion and 28 to no intervention. One woman was enrolled before the trial registration date (June 19, 2012). Perinatal mortality rates were 18 of 28 (64{\%}) in the amnioinfusion group vs 21 of 28 (75{\%}) in the no intervention group (relative risk 0.86, 95{\%} CI 0.60-1.22, P=.39). CONCLUSION: In women with second-trimester preterm prelabor rupture of membranes and oligohydramnios, we found no reduction in perinatal mortality after amnioinfusion. CLINICAL TRIAL REGISTRATION: NTR Dutch Trial Register, NTR3492.",
author = "{van Kempen}, {Liselotte E.M.} and {van Teeffelen}, {Augustinus S.} and {de Ruigh}, {Annemijn A.} and Dick Oepkes and Haak, {Monique C.} and {van Leeuwen}, Elisabeth and Mallory Woiski and Porath, {Martina M.} and Bax, {Caroline J.} and {van Wassenaer-Leemhuis}, {Aleid G.} and Mulder, {Antonius L.} and {van der Ham}, {David P.} and Christine Willekes and Franssen, {Maureen T.} and Derks, {Jan B.} and Ewoud Schuit and Mol, {Ben W.} and Eva Pajkrt",
year = "2019",
month = "1",
day = "1",
doi = "10.1097/AOG.0000000000003003",
language = "English",
volume = "133",
pages = "129--136",
journal = "Obstetrics and Gynecology",
issn = "0029-7844",
publisher = "Lippincott Williams & Wilkins",
number = "1",

}

van Kempen, LEM, van Teeffelen, AS, de Ruigh, AA, Oepkes, D, Haak, MC, van Leeuwen, E, Woiski, M, Porath, MM, Bax, CJ, van Wassenaer-Leemhuis, AG, Mulder, AL, van der Ham, DP, Willekes, C, Franssen, MT, Derks, JB, Schuit, E, Mol, BW & Pajkrt, E 2019, 'Amnioinfusion Compared With No Intervention in Women With Second-Trimester Rupture of Membranes: A Randomized Controlled Trial' Obstetrics and Gynecology, vol. 133, no. 1, pp. 129-136. https://doi.org/10.1097/AOG.0000000000003003

Amnioinfusion Compared With No Intervention in Women With Second-Trimester Rupture of Membranes : A Randomized Controlled Trial. / van Kempen, Liselotte E.M.; van Teeffelen, Augustinus S.; de Ruigh, Annemijn A.; Oepkes, Dick; Haak, Monique C.; van Leeuwen, Elisabeth; Woiski, Mallory; Porath, Martina M.; Bax, Caroline J.; van Wassenaer-Leemhuis, Aleid G.; Mulder, Antonius L.; van der Ham, David P.; Willekes, Christine; Franssen, Maureen T.; Derks, Jan B.; Schuit, Ewoud; Mol, Ben W.; Pajkrt, Eva.

In: Obstetrics and Gynecology, Vol. 133, No. 1, 01.01.2019, p. 129-136.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Amnioinfusion Compared With No Intervention in Women With Second-Trimester Rupture of Membranes

T2 - Obstetrics and Gynecology

AU - van Kempen, Liselotte E.M.

AU - van Teeffelen, Augustinus S.

AU - de Ruigh, Annemijn A.

AU - Oepkes, Dick

AU - Haak, Monique C.

AU - van Leeuwen, Elisabeth

AU - Woiski, Mallory

AU - Porath, Martina M.

AU - Bax, Caroline J.

AU - van Wassenaer-Leemhuis, Aleid G.

AU - Mulder, Antonius L.

AU - van der Ham, David P.

AU - Willekes, Christine

AU - Franssen, Maureen T.

AU - Derks, Jan B.

AU - Schuit, Ewoud

AU - Mol, Ben W.

AU - Pajkrt, Eva

PY - 2019/1/1

Y1 - 2019/1/1

N2 - OBJECTIVE: To assess the effectiveness of amnioinfusion in women with second-trimester preterm prelabor rupture of membranes. METHODS: We performed a nationwide, multicenter, open-label, randomized controlled trial, the PPROM: Expectant Management versus Induction of Labor-III (PPROMEXIL-III) trial, in women with singleton pregnancies and preterm prelabor rupture of membranes at 16 0/7 to 24 0/7 weeks of gestation with oligohydramnios (single deepest pocket less than 20 mm). Participants were allocated to transabdominal amnioinfusion or no intervention in a one-to-one ratio by a web-based system. If the single deepest pocket was less than 20 mm on follow-up visits, amnioinfusion was repeated weekly until 28 0/7 weeks of gestation. The primary outcome was perinatal mortality. We needed 56 women to show a reduction in perinatal mortality from 70% to 35% (β error 0.20, two-sided α error 0.05). RESULTS: Between June 15, 2012, and January 13, 2016, we randomized 28 women to amnioinfusion and 28 to no intervention. One woman was enrolled before the trial registration date (June 19, 2012). Perinatal mortality rates were 18 of 28 (64%) in the amnioinfusion group vs 21 of 28 (75%) in the no intervention group (relative risk 0.86, 95% CI 0.60-1.22, P=.39). CONCLUSION: In women with second-trimester preterm prelabor rupture of membranes and oligohydramnios, we found no reduction in perinatal mortality after amnioinfusion. CLINICAL TRIAL REGISTRATION: NTR Dutch Trial Register, NTR3492.

AB - OBJECTIVE: To assess the effectiveness of amnioinfusion in women with second-trimester preterm prelabor rupture of membranes. METHODS: We performed a nationwide, multicenter, open-label, randomized controlled trial, the PPROM: Expectant Management versus Induction of Labor-III (PPROMEXIL-III) trial, in women with singleton pregnancies and preterm prelabor rupture of membranes at 16 0/7 to 24 0/7 weeks of gestation with oligohydramnios (single deepest pocket less than 20 mm). Participants were allocated to transabdominal amnioinfusion or no intervention in a one-to-one ratio by a web-based system. If the single deepest pocket was less than 20 mm on follow-up visits, amnioinfusion was repeated weekly until 28 0/7 weeks of gestation. The primary outcome was perinatal mortality. We needed 56 women to show a reduction in perinatal mortality from 70% to 35% (β error 0.20, two-sided α error 0.05). RESULTS: Between June 15, 2012, and January 13, 2016, we randomized 28 women to amnioinfusion and 28 to no intervention. One woman was enrolled before the trial registration date (June 19, 2012). Perinatal mortality rates were 18 of 28 (64%) in the amnioinfusion group vs 21 of 28 (75%) in the no intervention group (relative risk 0.86, 95% CI 0.60-1.22, P=.39). CONCLUSION: In women with second-trimester preterm prelabor rupture of membranes and oligohydramnios, we found no reduction in perinatal mortality after amnioinfusion. CLINICAL TRIAL REGISTRATION: NTR Dutch Trial Register, NTR3492.

UR - http://www.scopus.com/inward/record.url?scp=85058922802&partnerID=8YFLogxK

U2 - 10.1097/AOG.0000000000003003

DO - 10.1097/AOG.0000000000003003

M3 - Article

VL - 133

SP - 129

EP - 136

JO - Obstetrics and Gynecology

JF - Obstetrics and Gynecology

SN - 0029-7844

IS - 1

ER -