NCT04630548

Brief Summary

Sixty six women who plan to deliver a live birth singleton via cesarean delivery who desire a Copper IUD for postpartum contraception will be approached for study participation thenvwill be randomized equally into two groups using computer generated numbers. Group (A): (n=33) women IUD insertion post placental delivery (within 10mins) Group (B): (n=33) women IUD insertion post puerperal ( 6 to 8 weeks postpartum). Primary outcome will include IUD expulsion rate in both groups. Secondary outcomes will include other complications rates: missed threads (not seen by speculum examination), displaced IUD (more than 2 cm from the fundus in ultrasound), heavy puerperal bleeding, abdominal discomfort), Pregnancy rate, Discontinuation of the IUD usage and Satisfaction rate.

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
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

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

November 7, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

November 16, 2020

Status Verified

November 1, 2020

Enrollment Period

1.3 years

First QC Date

November 7, 2020

Last Update Submit

November 13, 2020

Conditions

IUD

Keywords

IUD insertionpost placental insertionpuerperal insertioncesarean section

Outcome Measures

Primary Outcomes (1)

  • IUD expulsion rate

    to measure the frequency of IUD expulsion (IUD not found in ultrasound) following insertion by ultrasound examination.

    6 months (following the insertion)

Secondary Outcomes (4)

  • Missed threads rate (threads not seen by speculum examination)

    6 months (following the insertion)

  • displaced IUD rate

    6 months (following the insertion)

  • pregnancy rate

    within the 1st 6 months after insertion

  • satisfaction rate

    6 months after insertion

Study Arms (2)

post placental IUD insertion

ACTIVE COMPARATOR

Following placental delivery, uterine cavity will be examined to exclude the presence of malformations or fibroids. Uterus will be stabilized by grasping it at fundus and the copper IUD (CuT 380 IUD) will be placed (within 10 minutes following the placental delivery) through the uterine wall incision high up in the uterine fundus (either by hand or using its applicator).

Device: Intrauterine copper device

post puerperal IUD insertion

ACTIVE COMPARATOR

IUD will be inserted 6 - 8 weeks following caesarean delivery (during the post puerperal visit).

Device: Intrauterine copper device

Interventions

Intrauterine copper deviceDEVICE

The obstetrical team will identify subjects who present in labor who meet the criteria and express interest in intrauterine contraception. Immediately after cesarean delivery, consented subjects will be randomized to immediate post placental IUD placement within 10 minutes or IUD placement at their routine standard postpartum visit (6 to 8 weeks postpartum).

post placental IUD insertionpost puerperal IUD insertion

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Singleton full term pregnancy at ≥37 weeks gestation confirmed by LMP and first trimesteric ultrasound.
  • Desired copper IUD placement for postpartum contraception.
  • Candidate for cesarean delivery.
  • Regional anesthesia.

You may not qualify if:

  • Anatomic uterine abnormalities distorting the uterine cavity (obstructive myomata, bicornuate, septate, etc)
  • Chorioamnionitis (also consider other risk factors such as prolonged rupture of membranes \>18 hours, prolonged labor \>24 hours, fever \>38C).
  • Puerperal sepsis.
  • Unresolved postpartum hemorrhage.
  • Known or suspected untreated endocervical gonorrhea, chlamydia.
  • Wilson's disease, copper allergy (Paragard only).
  • Known or suspected cervical or endometrial cancer or pelvic tuberculosis.
  • Prolonged procedure \> 2 hours.
  • Preoperative hemoglobin 9.5 gm/dl.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Intrauterine Devices, Copper

Intervention Hierarchy (Ancestors)

Intrauterine Devices, MedicatedIntrauterine DevicesContraceptive Devices, FemaleContraceptive DevicesEquipment and Supplies

Study Officials

  • moutaz M ELsherbini, MD

    assistant professor (faculty of medicine -Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Moutaz M Elsherbini, MD

CONTACT

01001588300Mizosherbini@yahoo.com

Mirna O Awad, MSc

CONTACT

01001401172mirnaawad91.ma@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 7, 2020

First Posted

November 16, 2020

Study Start

December 1, 2020

Primary Completion

March 30, 2022

Study Completion

April 30, 2022

Last Updated

November 16, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share