Dataset Information

Speculum versus digital insertion of Foley catheter for induction of labor in Nulliparas with unripe cervix: a randomized controlled trial.

ABSTRACT: BACKGROUND:Induction of labor (IoL) is an increasingly common obstetric procedure. Foley catheter IoL is recommended by WHO. It is associated with the lowest rate of uterine hyperstimulation syndrome and similar duration to delivery and vaginal delivery rate compared to other methods. Insertion is typically via speculum but digital insertion has been reported to be faster, better tolerated and with similar universal insertion success compared to speculum insertion in a mixed population of nulliparas and multiparas. Transcervical procedure is more challenging in nulliparas and when the cervix is unripe. We evaluated the ease and tolerability of digital compared to speculum insertion of Foley catheter for induction of labor in nulliparas with unripe cervixes. METHODS:A randomized trial was performed in a university hospital in Malaysia. Participants were nulliparas at term with unripe cervixes (Bishop Score???5) admitted for IoL who were randomized to digital or speculum-aided transcervical Foley catheter insertion in lithotomy position. Primary outcomes were insertion duration, pain score [11-point Visual Numerical Rating Scale (VNRS)], and failure. All primary outcomes were recorded after the first insertion. RESULTS:Data from 86 participants were analysed. Insertion duration (with standard deviation) was 2.72?±?1.85 vs. 2.25?±?0.55?min p?=?0.12, pain score (VNRS) median [interquartile range] 3.5 [2-5] vs. 3 [2-5] p?=?0.72 and failure 2/42 (5%) vs. 0/44 (0%) p?=?0.24 for digital vs speculum respectively. There was no significant difference found between the two groups for all three primary outcomes. Induction to delivery 30.7?±?9.4 vs 29.6?±?11.5?h p?=?0.64, Cesarean section 25/60 (64%) vs 28/64 (60%) RR 0.9 95% CI p?=?0.7 and maternal satisfaction VNRS score with the birth process 7 [IQR 6-8] vs 7 [7-8] p?=?0.97 for digital vs. speculum arms respectively. Other labor, delivery and neonatal secondary outcomes were not significantly different. CONCLUSION:Digital and speculum insertion in nulliparas with unripe cervixes had similar insertion performance. As digital insertion required less equipment and consumables, it could be the preferred insertion method for the equally adept and the insertion technique to train towards. TRIAL REGISTRATION:This trial was registered with ISRCTN registration number 13804902 on 15 November 2017.

SUBMITTER: Chia HM

PROVIDER: S-EPMC7257160 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Speculum versus digital insertion of Foley catheter for induction of labor in Nulliparas with unripe cervix: a randomized controlled trial.

Chia Hang Min HM Tan Peng Chiong PC Tan Sze Ping SP Hamdan Mukhri M Omar Siti Zawiah SZ

BMC pregnancy and childbirth 20200529 1

<h4>Background</h4>Induction of labor (IoL) is an increasingly common obstetric procedure. Foley catheter IoL is recommended by WHO. It is associated with the lowest rate of uterine hyperstimulation syndrome and similar duration to delivery and vaginal delivery rate compared to other methods. Insertion is typically via speculum but digital insertion has been reported to be faster, better tolerated and with similar universal insertion success compared to speculum insertion in a mixed population o ...[more]

PMID: 32471369

Similar Datasets

Project description:ObjectiveTo evaluate the rate of preterm birth (PTB) in a subsequent pregnancy in women who had undergone term induction using a Foley catheter compared with prostaglandins.MethodsThis was a follow-up study of two large randomized controlled trials (PROBAAT-1 and PROBAAT-2). In the original trials, women with a term singleton pregnancy with the fetus in cephalic presentation and with an indication for labor induction were randomized to receive either a 30-mL Foley catheter or prostaglandins (vaginal prostaglandin E2 in PROBAAT-1 and oral misoprostol in PROBAAT-2). Data on subsequent ongoing pregnancies > 16 weeks' gestation were collected from hospital charts from clinics participating in this follow-up study. The main outcome measure was preterm birth < 37 weeks' gestation in a subsequent pregnancy.ResultsFourteen hospitals agreed to participate in this follow-up study. Of the 1142 eligible women, 572 had been allocated to induction of labor using a Foley catheter and 570 to induction of labor using prostaglandins. Of these, 162 (14%) were lost to follow-up. In total, 251 and 258 women had a known subsequent pregnancy > 16 weeks' gestation in the Foley catheter and prostaglandin groups, respectively. There were no differences in baseline characteristics between the groups. The overall rate of PTB in a subsequent pregnancy was 9/251 (3.6%) in the Foley catheter group vs 10/258 (3.9%) in the prostaglandin group (relative risk (RR), 0.93; 95% CI, 0.38-2.24), and the rate of spontaneous PTB was 5/251 (2.0%) vs 5/258 (1.9%) (RR, 1.03; 95% CI, 0.30-3.51).ConclusionIn women with term singleton pregnancy, induction of labor using a 30-mL Foley catheter is not associated with an increased risk of PTB in a subsequent pregnancy, as compared to induction of labor using prostaglandins. © 2020 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Project description:BackgroundInduction of labour (IOL) is one of the commonest obstetric interventions, with significant impact on both the individual woman and health service delivery. Outpatient IOL is an attractive option to reduce these impacts. To date there is little data comparing outpatient and inpatient IOL methods, and potential safety concerns (hyperstimulation) if prostaglandins, the standard inpatient IOL medications, are used in the outpatient setting. The purpose of this study was to assess feasibility, clinical effectiveness and patient acceptability of outpatient Foley catheter (OPC) vs. inpatient vaginal PGE2 (IP) for induction of labour (IOL) at term.MethodsWomen with an unfavourable cervix requiring IOL at term (N=101) were randomised to outpatient care using Foley catheter (OPC, n=50) or inpatient care using vaginal PGE2 (IP, n=51). OPC group had Foley catheter inserted and were discharged overnight following a reassuring cardiotocograph. IP group received 2 mg/1 mg vaginal PGE2 if nulliparous or 1 mg/1 mg if multiparous. Main outcome measures were inpatient stay (prior to birth, in Birthing Unit, total), mode of birth, induction to delivery interval, adverse reactions and patient satisfaction.ResultsOPC group had shorter hospital stay prior to birth (21.3 vs. 32.4 hrs, p< .001), IP were more likely to achieve vaginal birth within 12 hours of presenting to Birthing Unit (53% vs. 28%, p= .01). Vaginal birth rates (66% OPC Vs. 71% IP), total induction to delivery time (33.5 hrs vs. 31.3 hrs) and total inpatient times (96 hrs OPC Vs. 105 hrs IP) were similar. OPC group felt less pain (significant discomfort 26% Vs 58%, p=.003), and had more sleep (5.8 Vs 3.4 hours, p< .001), during cervical preparation, but were more likely to require oxytocin IOL (88 Vs 59%, p=.001).ConclusionsOPC was feasible and acceptable for IOL of women with an unfavourable cervix at term compared to IP, however did not show a statistically significant reduction in total inpatient stay and was associated with increased oxytocin IOL.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN:12609000420246.

Dataset Information

Speculum versus digital insertion of Foley catheter for induction of labor in Nulliparas with unripe cervix: a randomized controlled trial.

Publications

Speculum versus digital insertion of Foley catheter for induction of labor in Nulliparas with unripe cervix: a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets