Misoprostol 400 µg Versus 200 µg for Cervical Ripening in 1st Trimester Miscarriage

NCT02957305 | Completed Phase 4 Results

• 1 other identifier: 160309
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

Brief Summary

Local current protocol for cervical ripening in 1st trimester miscarriage recommends 400 µg of misoprostol intravaginally 3 hours before uterine evacuation. This regime has been recommended by some international guidelines . So far, there are no recent studies comparing cervical dilatation between 400 µg of misoprostol and a reduced dose (e.g., 200 µg) for 6 hours. If cervical ripening is similar between these two regimens(i.e., 200µg regimen is not inferior to 400µg regimen), costs reductions and lower side effects may be issued without losing quality of cervix dilatation.

Conditions

Miscarriage in First Trimester

Keywords

misoprostol; miscarriage

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Required Cervix Dilation at Initiation of the Manual Vacuum Aspiration

  this outcome identifies patients that had to have a mechanical dilator for opening the cervix to perform appropriate Manual Vacuum Aspiration

  baseline at initiation of the Manual Vacuum Aspiration

Secondary Outcomes (1)

• Number of Participants With a Presence of a Uterine Cervical Canal With ≥8 mm of Dilation

  Baseline before Manual Vacuum Aspiration procedure

Other Outcomes (1)

• Pain Score (VAS)

  before Manual Vacuum Aspiration

Study Arms (2)

Misoprostol 400 µg

ACTIVE COMPARATOR

Participants received misoprostol 400 µg: 2 tablets of misoprostol (200µg each) introduced into the vagina, at least 6 hours before the Manual Vacuum Aspiration (MVA) procedure.

Drug: Misoprostol 400mcg Tab

Misoprostol 200 µg

EXPERIMENTAL

Participants received misoprostol 200 µg: 1 tablet of misoprostol introduced into the vagina, at least 6 hours before the Manual Vacuum Aspiration procedure.

Drug: Misoprostol 200mcg Tab

Interventions

Misoprostol 400mcg Tab DRUG

400µg of misoprostol (2 tablets)

Also known as: Misoprostol control

Misoprostol 400 µg

Misoprostol 200mcg Tab DRUG

200µg of misoprostol (1 tablet)

Also known as: Misoprostol comparator

Misoprostol 200 µg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All patients admitted at the Gynecological emergency Unit at Hospital de Clínicas de Porto Alegre scheduled for uterine evacuation with \<12 weeks of gestation.

You may not qualify if:

• patients who do not wish to participate in the project;
• patients with ectopic pregnancy;
• patients with comorbidities (heart failure congestive, chronic obstructive pulmonary disease);
• patients with hypovolemic shock;
• patients with cervical incompetence;
• patients with infected miscarriage/abortion (presence of fever, pus from the cervix, leukocytosis \[\> 14000\]);
• patients with twin pregnancy;
• patients with Marfan syndrome;
• patients allergic to misoprostol;
• patients with coagulopathy;
• patients with opening of cervical internal os (4 mm of dilatation at the time of consultation);
• patients with previous surgery of the cervix (conization);
• patients with concomitant use of IUDs.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

HCPA

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (6)

• Kapp N, Lohr PA, Ngo TD, Hayes JL. Cervical preparation for first trimester surgical abortion. Cochrane Database Syst Rev. 2010 Feb 17;2010(2):CD007207. doi: 10.1002/14651858.CD007207.pub2.

  PMID: 20166091 BACKGROUND

• Blanchard K, Clark S, Winikoff B, Gaines G, Kabani G, Shannon C. Misoprostol for women's health: a review. Obstet Gynecol. 2002 Feb;99(2):316-32. doi: 10.1016/s0029-7844(01)01701-x.

  PMID: 11814515 BACKGROUND

• Marret H, Simon E, Beucher G, Dreyfus M, Gaudineau A, Vayssiere C, Lesavre M, Pluchon M, Winer N, Fernandez H, Aubert J, Bejan-Angoulvant T, Jonville-Bera AP, Clouqueur E, Houfflin-Debarge V, Garrigue A, Pierre F; College national des gynecologues obstetriciens francais. Overview and expert assessment of off-label use of misoprostol in obstetrics and gynaecology: review and report by the College national des gynecologues obstetriciens francais. Eur J Obstet Gynecol Reprod Biol. 2015 Apr;187:80-4. doi: 10.1016/j.ejogrb.2015.01.018. Epub 2015 Jan 31.

  PMID: 25701235 BACKGROUND

• National Collaborating Centre for Women's and Children's Health (UK). Ectopic Pregnancy and Miscarriage: Diagnosis and Initial Management in Early Pregnancy of Ectopic Pregnancy and Miscarriage. London: RCOG Press; 2012 Dec. Available from http://www.ncbi.nlm.nih.gov/books/NBK132775/

  PMID: 23638497 BACKGROUND

• ACOG Committee Opinion. American College of Obstetrician and Gynecologist. ACOG Committee Opinion. Number 283, May 2003. New U.S. Food and Drug Administration labeling on Cytotec (misoprostol) use and pregnancy. Obstet Gynecol. 2003 May;101(5 Pt 1):1049-50. doi: 10.1016/s0029-7844(03)00396-x.

  PMID: 12738178 BACKGROUND

• Tang J, Kapp N, Dragoman M, de Souza JP. WHO recommendations for misoprostol use for obstetric and gynecologic indications. Int J Gynaecol Obstet. 2013 May;121(2):186-9. doi: 10.1016/j.ijgo.2012.12.009. Epub 2013 Feb 19.

  PMID: 23433680 BACKGROUND

MeSH Terms

Conditions

Abortion, Spontaneous

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Limitations and Caveats

Technical problems with measurement leading to unreliable. Pregnancies with less than 8 weeks had their procedures completely done with small diameter Karman cannulas

Results Point of Contact

• Title: Ricardo Francalacci Savaris
• Organization: Dep. of Obstetrics and Gynecology, Universidade Federal do Rio Grande do Sul, Porto Alegre - RS - Brazil

rsavaris@hpca.edu.br

+5551997781966

Study Officials

• Ricardo F Ricardo, MD, PhD

  HCPA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients, operators and statistical analysis were performed blindly.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Gynecologic Emergency Unit

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 7, 2016
• Study Start: December 21, 2016
• Primary Completion: October 19, 2019
• Study Completion: June 30, 2020
• Last Updated: April 30, 2021
• Results First Posted: September 3, 2020

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: unlimited
• Access Criteria: free to read

Locations

BR (1)