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Efficacy of Dilapan S compared to foley balloon in preinduction cervical ripening-a noninferiority trial.

作者信息

Leela Krishna Priya, Somasundaram Maheswari, Nujum Zinia T, Maheshwari Subbarayan Latha

机构信息

Department of Obstetrics and Gynaecology, PSGIMSR, Coimbatore, Tamil Nadu, India (Leela, Somasundaram).

Government Medical College, Kollam, Kerala, India (Nujum).

出版信息

AJOG Glob Rep. 2024 Aug 13;4(4):100387. doi: 10.1016/j.xagr.2024.100387. eCollection 2024 Nov.


DOI:10.1016/j.xagr.2024.100387
PMID:39385802
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11462052/
Abstract

BACKGROUND: The need for induction of labor is increasing in present obstetric practice. The available non-pharmacological methods for cervical ripening at term are Foley balloon and Dilapan-S. With the gaining popularity of Dilapan-S worldwide, there are very few clinical trials conducted in India to evaluate its effectiveness. OBJECTIVE: To compare the efficacy of Dilapan-S and Foley balloons for pre-induction cervical ripening. STUDY DESIGN: This single-center randomized non-inferiority trial included primi- and multi-gravida women between 37 and 41 weeks of gestation and unfavourable cervix with a Bishop's score between 0 and 2. Using a random number table, patients were assigned to study Group 1 Dilapan-S and to control Group 2 Foley balloon. Dilapan-S or Foley balloon was inserted intracervically and assessed for dilation after 12 hours. Patients with unfavourable dilatation were further provided prostaglandins (PgE 1 and 2) for further augmentation of induction. Primary outcome measures included improvement in Bishop's score, and mode of delivery, followed by time to delivery from intervention, use of other augmentation methods, and maternal and neonatal outcomes. RESULTS: After screening, 296 patients with Bishop score less than 2, (148 in each group) were enrolled in the study. The number of patients who had vaginal delivery was comparable between both groups (=.72), and so were the maternal outcomes. Two cases of cord prolapse occurred with Foley balloon. Group 2 showed significant improvement in Bishop's score (<.001), and Group 1 had a significantly higher use of augmentation with PgE1 (-.01) and PgE2 (<.001). The number of contractions was significantly lower in Group 1 (<.001), and contraction intensity was higher in Group 2. There was no significant difference in cesarean delivery for failed induction of labor between the groups (=.72). Based on the primary outcome measure, Dilapan-S was found to be non-inferior to the Foley balloon. CONCLUSION: Dilapan-S is non-inferior to Foley balloon in achieving pre-induction cervical ripening in term pregnancies, and therefore Dilapan-S can be suggested as an alternative in clinical practice with minimal risks.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fe5a/11462052/74671ccf635b/gr5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fe5a/11462052/aa2eb49e6b9d/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fe5a/11462052/7b287d5bfab2/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fe5a/11462052/ff575b30e3b1/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fe5a/11462052/07b844d6246d/gr4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fe5a/11462052/74671ccf635b/gr5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fe5a/11462052/aa2eb49e6b9d/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fe5a/11462052/7b287d5bfab2/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fe5a/11462052/ff575b30e3b1/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fe5a/11462052/07b844d6246d/gr4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fe5a/11462052/74671ccf635b/gr5.jpg

相似文献

[1]
Efficacy of Dilapan S compared to foley balloon in preinduction cervical ripening-a noninferiority trial.

AJOG Glob Rep. 2024-8-13

[2]
A randomized controlled trial of Dilapan-S vs Foley balloon for preinduction cervical ripening (DILAFOL trial).

Am J Obstet Gynecol. 2019-2-18

[3]
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Am J Perinatol. 2021-8

[4]
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[5]
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Am J Obstet Gynecol MFM. 2023-11

[6]
Synthetic Osmotic Dilators for Pre-Induction Cervical Ripening - an Evidence-Based Review.

Geburtshilfe Frauenheilkd. 2023-7-7

[7]
Early vs. delayed amniotomy in individuals undergoing pre-induction cervical ripening with transcervical Foley balloon: a meta-analysis.

Am J Obstet Gynecol MFM. 2024-8

[8]
A comparison between labor induction with only Dilapan-S and a combination of mifepristone and Dilapan-S in nulliparous women: a prospective pilot study.

J Matern Fetal Neonatal Med. 2021-9

[9]
A comparison of 30-, 50-, and 60-mL foley catheter balloon volume and time to achieve cervical ripening for labor induction: A triple-blind randomized controlled trial.

Niger J Clin Pract. 2023-7

[10]
Preinduction cervical ripening: prostaglandin E2 gel vs hygroscopic mechanical dilator.

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本文引用的文献

[1]
Synthetic Osmotic Dilators for Pre-Induction Cervical Ripening - an Evidence-Based Review.

Geburtshilfe Frauenheilkd. 2023-7-7

[2]
Variations in the prevalence of caesarean section deliveries in India between 2016 and 2021 - an analysis of Tamil Nadu and Chhattisgarh.

BMC Pregnancy Childbirth. 2023-8-30

[3]
Pre-cervical ripening and hygroscopic cervical dilators in pre-labor induction.

J Matern Fetal Neonatal Med. 2023-12

[4]
A Review of the Mechanism of Action and Clinical Applications of Osmotic Dilators for Cervical Ripening in the Induction of Labor and in Gynecology Procedures.

Med Sci Monit. 2023-6-27

[5]
Comparison of Maternal Labor-Related Complications and Neonatal Outcomes Following Elective Induction of Labor at 39 Weeks of Gestation vs Expectant Management: A Systematic Review and Meta-analysis.

JAMA Netw Open. 2023-5-1

[6]
A randomized trial of synthetic osmotic cervical dilator for induction of labor vs dinoprostone vaginal insert.

Am J Obstet Gynecol MFM. 2022-7

[7]
To Study the Maternal and Neonatal Outcome in Postdated Women Undergoing Induction of Labour Versus Spontaneous Labour.

J Obstet Gynaecol India. 2021-4

[8]
A comparison between labor induction with only Dilapan-S and a combination of mifepristone and Dilapan-S in nulliparous women: a prospective pilot study.

J Matern Fetal Neonatal Med. 2021-9

[9]
A randomized controlled trial of Dilapan-S vs Foley balloon for preinduction cervical ripening (DILAFOL trial).

Am J Obstet Gynecol. 2019-2-18

[10]
Effects of induction of labor prior to post-term in low-risk pregnancies: a systematic review.

JBI Database System Rev Implement Rep. 2019-2

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