NCT03724708

Brief Summary

the investigators are trying to determine if this method of intrauterine device (IUD) insertion "hang up technique" has less expulsion rates than 6 week insertion or immediate post-placental insertion.

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
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 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

First Submitted

Initial submission to the registry

October 16, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 30, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

December 2, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

December 4, 2018

Status Verified

December 1, 2018

Enrollment Period

8 months

First QC Date

October 16, 2018

Last Update Submit

December 2, 2018

Conditions

IUD Insertion ComplicationIUD; Complications, Infection or Inflammation

Keywords

IUD expulsionhang up techniquepostpartum insertion

Outcome Measures

Primary Outcomes (1)

  • Expulsion rates

    IUD expulsion among the 3 groups at different intervals 24hours, 6 weeks, 3 and 6months postpartum

    6months

Secondary Outcomes (4)

  • Temperature

    24 hours

  • Irregular bleeding

    6 months.

  • Vaginitis

    6 months

  • postpartum hemorrhage

    24 hours

Study Arms (3)

Hang up technique

EXPERIMENTAL

where the enrolled patients will have the IUD applied in the middle of the uterine cavity and then attached to the fundus of the uterus by an absorbable suture "Hang up technique"

Device: IUD

Postpartum insertion

ACTIVE COMPARATOR

will include patients where IUD will be inserted after 6 weeks post-partum.

Device: IUD

Control

ACTIVE COMPARATOR

will serve as our control group where the enrolled patients will have the IUD just applied into the middle of the uterine cavity at the level of the fundus without attachment

Device: IUD

Interventions

IUDDEVICE

IUD insertion

ControlHang up techniquePostpartum insertion

Eligibility Criteria

Age22 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Full term patients (≥ 37 weeks gestation).
  • Singleton pregnancy.
  • Elective cesarean section for an uncomplicated pregnancy.
  • Healthy uterine cavity (no fibroid and no congenital anomaly) (Previously documented by history taking and/or ultrasound before pregnancy, and to be re-confirmed intraoperative).

You may not qualify if:

  • Preterm labor.
  • Uterine fibroid distorting uterine cavity.
  • History suggestive of previous pelvic inflammatory disease (Fever due to vaginal infection, ovarian abscess, repeated offensive vaginal infection, hydro/pyo-salpinx) 2
  • Rupture of membrane more than 12 hours.
  • Multi-fetal pregnancy
  • Placenta previa.
  • Previous uterine surgery other than CS
  • Documented congenital uterine anomalies intraoperative.
  • History of IUD insertion before this pregnancy with side effects like "bleeding, ectopic pregnancy, expulsion, pelvic inflammatory disease"
  • Uterine atony after delivery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

obstetrics and gynecology department, Kasr Alainy hospital

Cairo, 11562, Egypt

RECRUITING

Related Publications (3)

  • Goldstuck ND, Wildemeersch D. Role of uterine forces in intrauterine device embedment, perforation, and expulsion. Int J Womens Health. 2014 Aug 7;6:735-44. doi: 10.2147/IJWH.S63167. eCollection 2014.

    PMID: 25143756BACKGROUND

  • Chen BA, Reeves MF, Hayes JL, Hohmann HL, Perriera LK, Creinin MD. Postplacental or delayed insertion of the levonorgestrel intrauterine device after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2010 Nov;116(5):1079-87. doi: 10.1097/AOG.0b013e3181f73fac.

    PMID: 20966692BACKGROUND

  • Tjahjanto H, Haryuni IT. Hang-up IUD, new technique for suturing CuT-380A IUD to uterine fundus in immediate postplacental insertion during cesarean delivery: twelve months follow up. Indones J Obstet Ginecol. 2014;2-31:132-139.

    BACKGROUND

MeSH Terms

Conditions

InfectionsInflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mamoud Soliman, M.D.

    Lecturer of obstetrics and gynecology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Kamel, M.D.

CONTACT

00201120022332dr.ahmed.m.kamel@gmail.com

Mahmoud Soliman, M.D.

CONTACT

00201002166159dr_mahmoudsoliman@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
randomised computer generated table and closed envelope system
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Professor of obstetrics and gynecology

Study Record Dates

First Submitted

October 16, 2018

First Posted

October 30, 2018

Study Start

December 2, 2018

Primary Completion

August 1, 2019

Study Completion

September 1, 2019

Last Updated

December 4, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)