{
  "abstract": "Background\n\nIn regions where mifepristone access is legally or logistically constrained, second-trimester pregnancy termination predominantly relies on misoprostol-only regimens. However, these protocols are often associated with a prolonged induction-to-abortion interval (IAI). This study evaluated whether integrating mechanical cervical ripening agents-specifically Foley catheters or Dilapan-S rods-could enhance the clinical efficiency of misoprostol-induced terminations in mifepristone-restricted settings.Materials and methods\n\nIn this single-center, open-label randomized controlled trial (February-October 2023), 90 women with singleton pregnancies between 13 + 0 and 20 + 6 weeks' gestation were randomly assigned (1:1:1 ratio) to one of three groups: (1) vaginal misoprostol monotherapy (400 µg every 3 h); (2) misoprostol plus a 24F Foley catheter (balloon inflated to 40 mL); or (3) misoprostol following a 4-h cervical preparation with a Dilapan-S osmotic dilator. Sample size was calculated to detect a 30% reduction in median IAI (α = 0.05, β = 0.20), requiring 75 participants; 90 were enrolled to account for 20% attrition. Randomization employed computer-generated blocks with allocation concealment via SNOSE (sequentially numbered, opaque, sealed envelopes). Primary outcomes were IAI and total procedure time. Secondary outcomes included 24-h success rate, cumulative misoprostol dose, adverse events, and patient-reported acceptability. Statistical analyses used Kruskal-Wallis, Chi-square, and Kaplan-Meier log-rank tests, with significance defined as P < 0.05.Results\n\nMedian IAI did not differ significantly among groups (misoprostol: 600 min, Foley: 714 min, Dilapan-S: 698 min; P = 0.54). Total procedure time was significantly longer in the Dilapan-S group (938 min) compared with misoprostol alone (600 min) and Foley catheter (714 min; P = 0.02). The 24-h success rate was 67.5% overall, with no significant between-group differences (P = 0.26). No major complications occurred.Conclusion\n\nAdjunctive use of Foley catheters or Dilapan-S does not accelerate the induction-to-abortion process in second-trimester terminations compared with misoprostol monotherapy in mifepristone-restricted settings. Given the significantly longer total procedure time of Dilapan-S and its 15-fold higher cost without clinical benefit, vaginal misoprostol monotherapy remains the most pragmatic and cost-effective strategy. Larger multicenter trials are warranted to detect potentially subtle differences in clinical efficacy.Trial registration\n\nIranian Registry of Clinical Trials (IRCT20210516051312N2).",
  "abstract_shown": true,
  "affiliations": [
    "Department of Obstetrics and Gynecology, School of Medicine, Dezful University of Medical Sciences, Dezful, Iran.",
    "Student Research Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.",
    "Department of Midwifery, Mara.C., Islamic Azad University, Marand, Iran.",
    "Faculty of Nursing, Dezful University of Medical Sciences, Dezful, Iran.",
    "Student Research Committee, Dezful University of Medical Sciences, Dezful, Iran."
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 5,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Neda Torabifar"
    },
    {
      "affs": [
        0,
        1
      ],
      "name": "Fatemeh Yousefi"
    },
    {
      "affs": [
        2
      ],
      "name": "Shahla Faal Siahkal"
    },
    {
      "affs": [
        3,
        4
      ],
      "name": "Sara Kord"
    },
    {
      "affs": [
        0
      ],
      "name": "Salimeh Moradinasab"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/d18ycv9ws8cz2.bib",
  "cited_by": 0,
  "doi": "10.4103/jehp.jehp_55_26",
  "fulltext_url": "https://europepmc.org/articles/PMC13690145",
  "id": "d18ycv9ws8cz2",
  "issns": [
    "2277-9531",
    "2319-6440"
  ],
  "landing_url": "https://europepmc.org/article/MED/42923805",
  "language": "eng",
  "licence": "CC-BY-NC-ND",
  "licence_label": "CC BY-NC-ND",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc-nd/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "2739|Reproductive Health and Contraception"
    ]
  ],
  "openalex": "W7215117498",
  "pdf_url": "https://europepmc.org/articles/PMC13690145?pdf=render",
  "pmcid": "PMC13690145",
  "pmid": "42923805",
  "published": "2026-09-30",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/d18ycv9ws8cz2.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:20:36Z",
      "native_id": "MED:42923805",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42923805"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2739|Reproductive Health and Contraception",
      "subfield": "epidemiology-public-health"
    }
  ],
  "title": "Misoprostol monotherapy versus adjunctive mechanical cervical ripening with Foley catheter or Dilapan-S for second-trimester termination of pregnancy: A randomized controlled trial.",
  "title_text": "Misoprostol monotherapy versus adjunctive mechanical cervical ripening with Foley catheter or Dilapan-S for second-trimester termination of pregnancy: A randomized controlled trial.",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:20:36Z",
  "url": "https://research.draconitic.com/paper/d18ycv9ws8cz2",
  "venue": "Journal of education and health promotion",
  "versions": []
}