Different Routes of Misoprostol Prior to First Trimester Surgical Abortion

Different Routes of Misoprostol for Same-day Cervical Preparation Prior to First Trimester Surgical Abortion: a Randomized Controlled Trial

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02480543

Enrollment

120

Registered

2015-06-24

Start date

2015-07-31

Completion date

2016-07-31

Last updated

2016-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abortion, Induced

Brief summary

A randomized clinical trial to assess the effectiveness of same-day cervical preparation with oral, buccal or vaginal Misoprostol, given 2-4 hours prior first trimester curettage.

Interventions

DRUGMisoprostol (cytotec)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Patients admitted for elective first trimester abortion (termination of pregnancy/ missed abortion) at Wolfson Medical Center, gestational age \<13+0 weeks * Written consent supplied

Exclusion criteria

* Contraindications to prostaglandin treatment (severe asthma, glaucoma, severe cardiac disease, renal failure) * Prostaglandin allergy * Genital infection * Space-occupying lesion in the endocervical canal * Prior cervical surgery

Design outcomes

Primary

Measure	Time frame	Description
Preoperative cervical width in centimeters	intraoperative	• Initial cervical dilatation assessed by performing cervical dilatation , beginning with a number 10 Hegar dilator and subsequently inserting smaller Hegar dilators until the dilator can pass through the internal os without resistance. The largest one to pass will consist the initial cervical width.

Secondary

Measure	Time frame	Description
Time required to achieve cervical dilatation	intraoperative	The time in minutes required for dilatation up to a number 10 Hegar
Ease of cervical dilatation	intraoperative	The subjective ease of cervical dilatation recorded by the surgeon on a 5-point Likert scale (1-very difficult, 5- very easy
Patient preference	baseline	Patient acceptability of the administration of medication on a 5-point Likert scale (1-very uncomfortable, 5-very comfortable)
Adverse effects of medication	baseline	Self reported misoprostol-associated adverse effects before the procedure (such as nausea, vomiting)
Surgical complications	intraoperative	Complications arising during surgery (perforation, cervical laceration, excess bleeding)

Countries

Israel

Contacts

Primary ContactHadas Ganer Herman, MD

hadassganer@yahoo.com972-077-2066960

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026