NCT05283798

Brief Summary

To compare efficacy safety \& side effects of multiload 375 IUD versus copper T 380 IUD when inserted during elective CS

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

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

October 5, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 17, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 17, 2022

Status Verified

October 1, 2021

Enrollment Period

4 months

First QC Date

October 5, 2021

Last Update Submit

March 8, 2022

Conditions

IUD

Outcome Measures

Primary Outcomes (1)

  • expulsion rate after 6 weeks of insertion

    compare expulsion rates between the two types after 6 weeks by ultrasoud

    6 weeks

Secondary Outcomes (1)

  • compare bleedind dayes and shift to anthor methoud

    6 weeks

Study Arms (2)

rate of missed threads in the first 6 weeks

EXPERIMENTAL

To compare efficacy safety \& side effects of multiload 375 IUD versus copper T 380 IUD when inserted during elective CS

Device: IUD

number of bleeding days in first 6 weeks

OTHER

compare numbers of bleeding days in first 6 weeks and first 6 month

Device: IUD

Interventions

IUDDEVICE

Postpartum intra-caesarean section insertion of copper T380 versus multiload 375

number of bleeding days in first 6 weeksrate of missed threads in the first 6 weeks

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsall females in the reproductive age
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women delivered by elective CS ≥ 36 wks

You may not qualify if:

  • Patients with PROM Patients on corticosteroids therapy Patients on anticoagulant patients who refuse participate in the study with written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Mahmoud Abdelhameed

CONTACT

01096128561m7moud3bdel7ameed@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

October 5, 2021

First Posted

March 17, 2022

Study Start

August 1, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2023

Last Updated

March 17, 2022

Record last verified: 2021-10