NCT02248376

Brief Summary

The primary purpose of the study is to compare efficiency of a non-stick gel application after scraping surgery for natural miscarriage with no non-stick gel application after scraping surgery. Post-scraping uterine synechiae rate will be established at the diagnostical hysteroscopy 6-8 weeks after surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
364

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2014

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

November 14, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2018

Completed
Last Updated

August 3, 2021

Status Verified

July 1, 2021

Enrollment Period

3.8 years

First QC Date

September 22, 2014

Last Update Submit

July 31, 2021

Conditions

Uterine Synechiae After Scraping for Natural Miscarriage

Keywords

Uterine synechiae Scraping surgery Natural miscarriage

Outcome Measures

Primary Outcomes (1)

  • Evaluation of post-surgical uterine synechiae rate during a diagnostical hysteroscopy.

    Diagnostical hysteroscopy performed 6-8 weeks after scraping surgery.

    6-8 weeks after scraping surgery

Secondary Outcomes (4)

  • Evaluation of the effect of the non-stick gel application on the post-surgical fertility 6, 12, and 24 months after scraping surgery.

    6, 12 and 24 months after scraping surgery

  • Evaluation of the obstetric complication rate 12 and 24 months after scraping surgery.

    Evaluation of the obstetric complication rate 12 and 24 months after scraping surgery.

  • Evaluation of post-surgical synechiae stretch and severity

    6-8 weeks after scraping surgery

  • Consistency assessment between synechiae evaluation performed at the diagnostical hysteroscopy and the synechiae evaluation performed by the 2 experts at the end of the study

    36 months

Study Arms (2)

Gel +

EXPERIMENTAL

Patients aged of more than 18 years-old coming for a natural miscarriage who will have the stick gel application at the end of the scraping surgery.

Drug: Gel

Gel -

NO INTERVENTION

Patients aged of more than 18 years-old coming for a natural miscarriage who will not have the non-stick gel application at the end of the scraping surgery.

Interventions

GelDRUG

Patients aged of more than 18 years-old coming for a natural miscarriage who will have the stick gel application at the end of the scraping surgery.

Gel +

Eligibility Criteria

Age18 Years - 46 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women patients aged between 18 and 46 years old
  • Term ≥ 7 weeks amenorrhea and ≤ 14 weeks amenorrhea
  • Blighted ovum or not completed miscarriage or haemorrhagic miscarriage or retention miscarriage
  • Consent signature
  • Social security coverage
  • Women who wants to be pregnant

You may not qualify if:

  • Infected miscarriage
  • Uncertain diagnosis between miscarriage and extra-uterine pregnancy
  • Hydatiform mole
  • Uterine synechiae history
  • Surgical zone infection
  • Hyalobarrier® gel Endo hypersensitivity
  • Clotting disorder
  • Unstable diabetes
  • Maternal malignant diseases
  • Psychiatric disorder
  • Incapacity in understanding the consent form and the questionnaires
  • Law protected adult person

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Lariboisière - Service de Gynécologie-Obstétrique

Paris, 75010, France

Location

Related Publications (1)

  • Sroussi J, Bourret A, Pourcelot AG, Thubert T, Lesavre M, Legendre G, Tuffet S, Rousseau A, Benifla JL; HYFACO group. Does hyaluronic acid gel reduce intrauterine adhesions after dilation and curettage in women with miscarriage? A Multicentric randomized controlled trial (HYFACO Study). Am J Obstet Gynecol. 2022 Oct;227(4):597.e1-597.e8. doi: 10.1016/j.ajog.2022.05.064. Epub 2022 Jun 3.

    PMID: 35667420DERIVED

MeSH Terms

Interventions

Gels

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Jean-Louis Benifla, MD-PhD

    Assistance Publique

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2014

First Posted

September 25, 2014

Study Start

November 14, 2014

Primary Completion

September 14, 2018

Study Completion

September 14, 2018

Last Updated

August 3, 2021

Record last verified: 2021-07

Locations

FR(1)