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COMPLETED NA

Misoprostol Dose and Timing Before Surgical Abortion at 13 to 16 Weeks' Gestation: a Randomized Trial

NCT02279914 · View on ClinicalTrials.gov ↗

Study Summary

This study is a blinded randomized trial to compare two different doses and intervals of buccal misoprostol for cervical preparation before surgical abortion at 13 to 16 weeks' gestation: 400 mcg administered 3 hours before D\&E (dilation and extraction), and 600 mcg administered 1.5 hours before D\&E. Primary objective: To compare operative times after two different doses and intervals of misoprostol using a non-inferiority design. Secondary objectives: To compare the doses and intervals of misoprostol for differences in: (1) initial cervical dilation; (2) need for mechanical dilation and ease of dilation if required; (3) ability to complete the abortion procedure without further cervical preparation; (4) complications; (5) provider variables including ease of procedure and satisfaction with cervical preparation; (6) patient variables including pre-operative side effects, post-operative pain, and acceptability

Conditions Studied

Interventions

  • DRUG Misoprostol 400 mcg 3 hours prior to procedure
  • DRUG Misoprostol 600 mcg 90 minutes prior to procedure

Study Locations (1)

New York

  • Planned Parenthood of New York City - Margaret Sanger Center — New York

Trial Details

FieldValue
Enrollment Target 118 participants
Start Date 2014-11
Est. Completion 2016-08
Phase NA

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02279914

The ClinicalTrials.gov registry entry for NCT02279914 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Planned Parenthood of Greater New York, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Abortion, Induced appearing as the primary indexed condition, and to 2 interventions — of which Misoprostol 400 mcg 3 hours prior to procedure is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02279914 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02279914 about?

NCT02279914 is a clinical study titled "Misoprostol Dose and Timing Before Surgical Abortion at 13 to 16 Weeks' Gestation: a Randomized Trial". This study is a blinded randomized trial to compare two different doses and intervals of buccal misoprostol for cervical preparation before surgical abortion at 13 to 16 weeks' gestation: 400 mcg administered 3 hours before D\&E (dilation and extraction), and 600 mcg administered 1.5 hours before D\...

What is the current status of trial NCT02279914?

This trial is currently completed. It is a NA study. The enrollment target is 118 participants. The study started on 2014-11. Estimated completion is 2016-08.

What conditions does trial NCT02279914 study?

This clinical trial studies the following conditions: Abortion, Induced. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02279914?

The interventions under investigation include: Misoprostol 400 mcg 3 hours prior to procedure (DRUG), Misoprostol 600 mcg 90 minutes prior to procedure (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02279914?

This trial is sponsored by Planned Parenthood of Greater New York, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02279914 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial