Amnioinfusion in very early preterm prelabor rupture of membranes (<scp>AMIPROM</scp>): pregnancy, neonatal and maternal outcomes in a randomized controlled pilot study

Roberts, Donald F.; Vause, Sarah; Martin, William Marty; Green, P.; Walkinshaw, S.; Bricker, Leanne; Beardsmore, Caroline; Shaw, N J; McKay, A. J.; Skotny, Gaynor; Williamson, PR; Alfirević, Z̄arko

doi:10.1002/uog.13258

Cited by 28 publications

(26 citation statements)

References 17 publications

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“…This information may be taken into consideration when counseling women with early PPROM, with regard to neonatal outcome and management options, particularly in the periviable period. In addition, our findings may support the concept of amnioinfusion in cases of early PPROM, which is a promising treatment option, although its effectiveness is currently still a topic of debate with limited trial data.…”

Section: Discussionsupporting

confidence: 65%

Amniotic fluid volume at presentation with early preterm prelabor rupture of membranes and association with severe neonatal respiratory morbidity

Weiner

Barrett

Zaltz

et al. 2019

Ultrasound in Obstet & Gyne

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Objective Amniotic fluid volume (AFV) plays an important role in early fetal lung development, and oligohydramnios in early pregnancy is associated with pulmonary hypoplasia. The aim of this study was to evaluate the association between AFV at the time of presentation with early preterm prelabor rupture of membranes (PPROM) and severe neonatal respiratory morbidity and other adverse pregnancy outcomes. Methods This was a retrospective study of all women with a singleton pregnancy, admitted to a single tertiary referral center between 2004 and 2014, for expectant management of PPROM at 20 + 0 to 28 + 6 weeks' gestation. The primary exposure was AFV at presentation, classified according to sonographic maximum vertical pocket (MVP) as: normal AFV (> 2 cm), oligohydramnios (≤ 2 cm and > 1 cm) or severe oligohydramnios (≤ 1 cm). The primary outcome was a composite variable of severe respiratory morbidity, defined as either of the following: (1) need for respiratory support in the form of mechanical ventilation using an endotracheal tube for ≥ 72 h and need for surfactant; or (2) bronchopulmonary dysplasia, defined as requirement for oxygen at postmenstrual age of 36 weeks or at the time of transfer to a Level‐II facility. Adjusted odds ratios (aOR) and 95% CI for the primary and secondary outcomes were calculated for each AFV‐at‐presentation group (using normal AFV as the reference), adjusting for gestational age (GA) at PPROM, latency period, birth weight, mode of delivery and chorioamnionitis. Results In total, 580 women were included, of whom 304 (52.4%) had normal AFV, 161 (27.8%) had oligohydramnios and 115 (19.8%) had severe oligohydramnios at presentation. The rates of severe respiratory morbidity were 16.1%, 26.7% and 45.2%, respectively. Compared with normal AFV at presentation, oligohydramnios (aOR, 3.27; 95% CI, 1.84–5.84) and severe oligohydramnios (aOR, 4.11; 95% CI, 2.26–7.56) at presentation were associated independently with severe respiratory morbidity. Other variables that were associated independently with the primary outcome were GA at PPROM (aOR, 0.54; 95% CI, 0.43–0.69), latency period (aOR, 0.94; 95% CI, 0.91–0.98) and Cesarean delivery (aOR, 2.01; 95% CI, 1.21–3.32). Conclusions In women with early PPROM, AFV at presentation, as assessed by the MVP on ultrasound examination, is associated independently with severe neonatal respiratory morbidity. This information may be taken into consideration when counseling women with early PPROM regarding neonatal outcome and management options. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.

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Section: Discussionsupporting

confidence: 65%

Amniotic fluid volume at presentation with early preterm prelabor rupture of membranes and association with severe neonatal respiratory morbidity

Weiner

Barrett

Zaltz

et al. 2019

Ultrasound in Obstet & Gyne

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“…This is achieved by regular on-site monitoring of data quality. PPROM management in the most vulnerable gestational age groups is still a matter of debate as conclusive studies are lacking [ 21 – 23 ]. Population-based registry data as presented here cannot overcome this problem but provide important epidemiological information to design a future randomized controlled trial.…”

Section: Discussionmentioning

confidence: 99%

Preterm Prelabor Rupture of Membranes and Outcome of Very-Low-Birth-Weight Infants in the German Neonatal Network

et al. 2015

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ObjectiveIt was the aim of our study to evaluate the independent effect of preterm prelabor rupture of membranes (PPROM) as a cause of preterm delivery on mortality during primary hospital stay and significant morbidities in very-low-birth-weight (VLBW) infants < 32 weeks of gestation.DesignObservational, epidemiological study design.SettingPopulation-based cohort, German Neonatal Network (GNN).Population6102 VLBW infants were enrolled in GNN from 2009-2012, n=4120 fulfilled criteria for primary analysis (< 32 gestational weeks, no pre-eclampsia, HELLP (highly elevated liver enzymes and low platelets syndrome) or placental abruption as cause of preterm birth).MethodsMultivariable logistic regression analyses included PPROM as potential risk factors for adverse outcomes and well established items such as gestational age in weeks, birth weight, antenatal steroids, center, inborn delivery, multiple birth, gender and being small-for-gestational-age.ResultsPPROM as cause of preterm delivery had no independent effect on the risk of early-onset sepsis, clinical sepsis and blood-culture proven sepsis, while gestational age proved to be the most important contributor to sepsis risk. The diagnosis of PPROM was associated with an increased risk for bronchopulmonary dysplasia (BPD; OR: 1.25, 95% CI: 1.02-1.55, p=0.03) but not with other major outcomes.ConclusionsThe diagnosis of PPROM per se is not associated with adverse outcome in VLBW infants < 32 weeks apart from a moderately increased risk for BPD. Randomized controlled trials with primary neonatal outcomes are needed to determine which subgroup of VLBW infants benefit from expectant or intentional management of PPROM.

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“…[5][6][7] Although many reports have used serial transabdominal amnioinfusion (TA) to treat oligoamnios, [8][9][10][11] recent randomized controlled trials (RCT) have refuted its effects. 12,13 Moreover, the reported maintenance rates of the amniotic fluid volume for more than 48 h following a single TA were only 24% and 31%, but the prognosis was different between cases with maintained amniotic fluid and cases without maintained amniotic fluid that underwent serial TA, 14,15 Reports of continuous TA to improve the prognosis of the infant by increasing the amniotic fluid maintenance rate are scarce, and these reports have suggested that TA prolongs pregnancy, [16][17][18] However, details about the controlled settings remain unclear, and there have been no detailed reports of the amniotic fluid maintenance rate and complications of continuous TA.…”

Section: Introductionmentioning

confidence: 99%

Continuous amnioinfusion for treatment of mid‐trimester preterm premature rupture of membranes with oligoamnios

Ono

Tsumura

Kawasaki

et al. 2019

J of Obstet and Gynaecol

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Aim Given the scarcity of relevant reports, this study aimed to elucidate whether pregnancy can be prolonged by maintaining the amniotic fluid volume with continuous transabdominal amnioinfusion (TA) for patients with mid‐trimester preterm premature rupture of membranes (PPROM) and oligoamnios. Methods We retrospectively examined patients who were managed during hospitalization at our department after developing PPROM between week 22 day 0 and week 25 day 6 of gestation and subsequent oligoamnios (amniotic fluid index [AFI] <5 cm) within 7 days after PPROM onset. Cases between 2006 and 2011 comprised the conventional management group (n = 14); cases administered continuous TA between 2012 and 2017 comprised the continuous TA group (n = 14). The primary outcome was the number of days between PPROM and delivery. The secondary outcomes were the proportion of normal amniotic fluid volume (AFI ≥ 5 cm) maintained between PPROM and delivery and the perinatal prognosis for the mother and infant. Results The continuous TA group had significantly more days between PPROM and delivery and a significantly higher proportion of days that a normal amniotic fluid volume was maintained during that period, regardless of antimicrobial agents administered. Although no significant differences in the perinatal prognosis of disease were found between groups, there was a decreasing trend of composite perinatal mortality and morbidity, and the incidence rates were reduced by half. Conclusion Continuous TA for PPROM with oligoamnios may allow significant prolongation of the gestation period while maintaining the amniotic fluid volume and may lead to improved perinatal prognosis.

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Amnioinfusion in very early preterm prelabor rupture of membranes (AMIPROM): pregnancy, neonatal and maternal outcomes in a randomized controlled pilot study

Abstract: Objective To assess short-and long-term outcomes of pregnant women with very early rupture of membranes randomized to serial amnioinfusion or expectant management, and to collect data to inform a larger, more definitive clinical trial. Methods (RR 9.0 (95% CI,

Cited by 28 publications

References 17 publications

Amniotic fluid volume at presentation with early preterm prelabor rupture of membranes and association with severe neonatal respiratory morbidity

Amniotic fluid volume at presentation with early preterm prelabor rupture of membranes and association with severe neonatal respiratory morbidity

Preterm Prelabor Rupture of Membranes and Outcome of Very-Low-Birth-Weight Infants in the German Neonatal Network

Continuous amnioinfusion for treatment of mid‐trimester preterm premature rupture of membranes with oligoamnios

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