NCT04501809

Brief Summary

it is a randomized controlled trial comparing the safety and efficacy of Vaginal Misoprostol versus combined Intracervical Foley's Catheter and Oxytocin Infusion for Second Trimester Pregnancy Termination. the patients will be sorted into 2 groups, Group I (Misoprostol group): seventy-nine patients and Group II (Combined group): seventy- nine patients. safety and efficacy of the procedure will be followed up and documented.

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
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

July 15, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

July 15, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 6, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

August 6, 2020

Status Verified

August 1, 2020

Enrollment Period

6 months

First QC Date

July 15, 2020

Last Update Submit

August 3, 2020

Conditions

Second Trimester Abortion

Keywords

abortion

Outcome Measures

Primary Outcomes (3)

  • time to cervical dilatation in hours

    time between starting the medications and the real cervical dilatation

    24 hours

  • induction abortion interval in hours

    time between induction of abortion and expulsion of the products of conception

    48 hours

  • need for surgical evacuation

    some cases may be presented with retained products of conception with the need for surgical evacuation of the uterus

    48 hours

Secondary Outcomes (4)

  • sever hemorrhage

    48 hours

  • patients satisfaction

    72 hours

  • post-abortive infection

    7 days

  • rupture uterus

    48 hours

Study Arms (2)

Group I (Misoprostol group):

ACTIVE COMPARATOR

seventy-nine patients will receive a loading dose of moistened misoprostol tablets ( Cytotec pfizer 400 mg) inserted vaginally and it will be followed by maintenance dose (200 mg) after six hours and repeated every 4 hours till the start of effective uterine contraction with maximum five doses in 24 hours duration .

Procedure: compare misoprostol with combined oxytocin and cervical foly catheter

Group II (Combined group):

ACTIVE COMPARATOR

seventy- nine patients will get intracervical Foleys Catheter insertion .a 16F (french units) Foley catheter will be introduced into the cervical canal to induce cervical ripping. The catheter will be fixed through inflation of the balloon with 30 milliliters of sterile solution when the catheter will be beyond the internal cervical os. After six hours of Foleys catheter fixation, we will start infusion of 10 international units (IU) of oxytocin on 500 ml ringer lactate by rate 125 ml\\hr followed by one hour rest to allow diuresis. Increased gradually of oxytocin dose by 5 IU each time until achieving regular uterine contraction, maximum five doses in twenty -four hours duration.

Procedure: compare misoprostol with combined oxytocin and cervical foly catheter

Interventions

compare misoprostol with combined oxytocin and cervical foly catheterPROCEDURE

we will compare using misoprostol alone in one group with oxytocin and cervical catheter in the other group

Group I (Misoprostol group):Group II (Combined group):

Eligibility Criteria

Age17 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • women indicated for termination of pregnancy between 14weeks-23 weeks and 6 days of gestation
  • singleton pregnancy
  • one or multiple cesarean delivery.

You may not qualify if:

  • bleeding disorders
  • chorioamnionitis
  • low-lying placenta
  • history of rupture uterus
  • history of myomectomy
  • contraindication to misoprostol
  • latex allergy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zagazig University

Zagazig, East, 44511, Egypt

RECRUITING

Tolba Ewida Street

Zagazig, Sharqia Province, 44511, Egypt

RECRUITING

Related Publications (1)

  • Elasy AN, Ibrahem MA, Elhawy LL, Hamed BM. Vaginal misoprostol versus combined intracervical foley's catheter and oxytocin infusion for second trimester pregnancy termination in women with previous caesarean sections: a randomised control trial. J Obstet Gynaecol. 2022 Oct;42(7):2962-2969. doi: 10.1080/01443615.2022.2118572. Epub 2022 Sep 23.

    PMID: 36149628DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of obstetrics and gynecology/ MD ob/gyn / consultant of obstetrics and gynecology

Study Record Dates

First Submitted

July 15, 2020

First Posted

August 6, 2020

Study Start

July 15, 2020

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

August 6, 2020

Record last verified: 2020-08

Locations

EG(2)