Induction of labour with retrievable prostaglandin vaginal inserts: outcomes following retrieval due to an intrapartum adverse event.
To assess adverse event (AE) resolution, delivery mode and neonatal outcomes after misoprostol or dinoprostone vaginal insert (MVI or DVI) retrieval due to AE during induction of labour (IOL).



Randomised, double-blind trial, EXPEDITE.



Thirty five obstetric departments, USA.



Consisted of 1358 pregnant women with modified Bishop score ≤4 eligible for pharmacological IOL.



Post hoc analysis.



AEs prompting insert retrieval, times to AE resolution, delivery, delivery mode and neonatal intensive care unit (NICU) admissions.



77/678 (11.4%) and 27/680 (4.0%) women had MVI and DVI retrieved due to AE, respectively (P < 0.001). The most common AEs prompting retrieval were uterine tachysystole with fetal heart rate (FHR) involvement and category II/III FHR pattern. Time to AE resolution varied for both treatments depending on the type of AE. For uterine tachysystole with FHR involvement, median resolution times were 1 hour 34.5 minutes (n = 36) and 8.5 minutes (n = 8) for MVI and DVI, respectively. Caesarean delivery occurred in a high proportion of women with insert retrieved due to AE (MVI: 44/77 (57.1%); DVI: 19/27 (70.4%)); the majority of caesareans were performed at least several hours after insert retrieval. Median times from retrieval to any delivery were not increased for women with insert retrieved due to AE. NICU admissions were 8/77 (10.4%) and 1/27 (3.7%) for MVI and DVI, respectively (P = 0.440).



AEs leading to insert retrieval were primarily uterine tachysystole with FHR involvement and category II/III FHR patterns. Insert retrieval due to an AE did not prolong time to delivery for either prostaglandin insert.



Induction with prostaglandin vaginal inserts: outcomes following retrieval due to intrapartum adverse event.
Ferring Pharmaceuticals, Copenhagen, Denmark.
O
O
Rugarn
Tipping Consulting LLC, Green Lane, PA, USA.
D
D
Tipping
Independent Consultant, Phoenixville, PA, USA.
B
B
Powers
Department of Obstetrics and Gynecology, University of California, Irvine, CA, USA.|Miller Children's and Women's Hospital, Long Beach, CA, USA.
D A
DA
Wing
D000282:Administration, Intravaginal; D000328:Adult; D002585:Cesarean Section / Q000706:statistics & numerical data; D015232:Dinoprostone / Q000008:administration & dosage / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007751:Labor, Induced / Q000009:adverse effects*; D016595:Misoprostol / Q000008:administration & dosage / Q000009:adverse effects*; D010120:Oxytocics / Q000008:administration & dosage / Q000009:adverse effects*; D011247:Pregnancy; D011256:Pregnancy Outcome / Q000453:epidemiology; D011453:Prostaglandins / Q000008:administration & dosage / Q000009:adverse effects*; D014481:United States; D028761:Withholding Treatment; D055815:Young Adult
D010120:Oxytocics; D011453:Prostaglandins; D016595:Misoprostol; D015232:Dinoprostone
Caesarean delivery; dinoprostone vaginal insert; induction of labour; intrapartum adverse events; misoprostol vaginal insert; neonatal outcomes