NCT05147857

Brief Summary

This study is done aiming to find out an effective method to induce second trimester abortion within a reasonable time and with the least possible cost and complications.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 7, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

December 7, 2021

Status Verified

November 1, 2021

Enrollment Period

1.9 years

First QC Date

November 10, 2021

Last Update Submit

November 23, 2021

Conditions

Abortion Early

Keywords

AbortionDilapan s

Outcome Measures

Primary Outcomes (1)

  • Abortion

    Abortion time in days

    24 hour from procedure

Secondary Outcomes (1)

  • Hospital stay

    24 hour from admission

Study Arms (2)

Mesotac in mid trimester

ACTIVE COMPARATOR

Prostaglandin

Drug: Misoprostol

Dilapan s in mid trimester

ACTIVE COMPARATOR

is an osmotic hygroscopic dilator produced from a patented Aquacryl® hydrogel that guarantees consistency of action. It is a rigid gel rod that increases in volume by absorbing fluids from the cervical canal, so it gradually dilates the cervix The thin 4 mm rod can expand up to 15 mm over a 12-24 hours period. This allows it to dilate and soften the cervix gradually.

Device: Dilapan s

Interventions

Dilapan sDEVICE

is an osmotic hygroscopic dilator produced from a patented Aquacryl® hydrogel that guarantees consistency of action. It is a rigid gel rod that increases in volume by absorbing fluids from the cervical canal, so it gradually dilates the cervix The thin 4 mm rod can expand up to 15 mm over a 12-24 hours period. This allows it to dilate and soften the cervix gradually.

Dilapan s in mid trimester
MisoprostolDRUG

Misoprostol is a synthetic prostaglandin medication used to prevent and treat stomach and duodenal ulcers, induce labor, cause an abortion, and treat postpartum bleeding due to poor contraction of the uterus. Misoprostol is taken by mouth when used to prevent gastric ulcers in persons taking NSAIDs.

Also known as: Misotac
Mesotac in mid trimester

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Sure indication of abortion.
  • Estimated gestational age between 12-24 weeks as calculated from last normal menstrual period (LNMP) and confirmed by abdominal ultrasound.
  • Intact membranes.
  • No medical disorder prevents the usage of any of the medications in the study.

You may not qualify if:

  • History of cervical surgery or presence of cervical scarring.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ainshams Maternity Hospital

Cairo, 11856, Egypt

RECRUITING

Related Publications (3)

  • Jones RK, Kooistra K. Abortion incidence and access to services in the United States, 2008. Perspect Sex Reprod Health. 2011 Mar;43(1):41-50. doi: 10.1363/4304111. Epub 2011 Jan 10.

    PMID: 21388504BACKGROUND

  • Pazol K, Creanga AA, Zane SB, Burley KD, Jamieson DJ; Centers for Disease Control and Prevention (CDC). Abortion surveillance--United States, 2009. MMWR Surveill Summ. 2012 Nov 23;61(8):1-44.

    PMID: 23169413RESULT

  • Johnson MR, Riddle AF, Grudzinskas JG, Sharma V, Collins WP, Nicolaides KH. Reduced circulating placental protein concentrations during the first trimester are associated with preterm labour and low birth weight. Hum Reprod. 1993 Nov;8(11):1942-7. doi: 10.1093/oxfordjournals.humrep.a137965.

    PMID: 7507132RESULT

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Salma Nassar, MD

    Ainshams maternity hospital

    STUDY DIRECTOR

  • Ayman Abo nour, Prof

    Ainshams maternity hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Reem Nasr, Master

CONTACT

01012926686reemnasr92@gmail.com

Salma Nasssar, MD

CONTACT

+20 100 167 3661

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 10, 2021

First Posted

December 7, 2021

Study Start

January 1, 2021

Primary Completion

November 30, 2022

Study Completion

December 30, 2022

Last Updated

December 7, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)