NCT05624411

Brief Summary

Clinical outcomes of post-placental insertion of Cupper T380A and Multiload 375 contraceptive devices during cesarean section

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

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 21, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

October 22, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 22, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

November 22, 2022

Status Verified

November 1, 2022

Enrollment Period

10 months

First QC Date

October 21, 2022

Last Update Submit

November 20, 2022

Conditions

IUD (Intrauterine Device) MalpositionIUD; Complications, Infection or Inflammation

Keywords

postplacental IUDIUDCupper T380A IUDMultiload 375 IUDiud expulsion

Outcome Measures

Primary Outcomes (1)

  • The expulsion rate of Multiload IUCD versus CopperT380A after post-placental insertion

    The expulsion rate of Multiload IUCD versus CopperT380A after post-placental insertion

    6 weeks

Secondary Outcomes (6)

  • Uterine bleeding

    6 weeks

  • Uterine bleeding

    6 weeks

  • Uterine bleeding

    6 weeks

  • PID

    6 weeks

  • perforation

    6 weeks

  • +1 more secondary outcomes

Study Arms (2)

A

post-placental insertion of CU T380A IUD during CS

Device: CU T380A IUD

B

post-placental insertion of multiload 375 IUD during CS

Device: multiload 375 IUD

Interventions

CU T380A IUDDEVICE

post-placental insertion of intrauterine contraceptive device

Also known as: CU T380A
A
multiload 375 IUDDEVICE

post-placental insertion of intrauterine contraceptive device

Also known as: multiload 375
B

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

All patients admitted for delivery at obstetric and gynecology emergency unit of sohag university hospital which is a tertiary center at sohag city in egypt who requested postpartum contraception, were invited to participate in the study

You may qualify if:

  • (1) All patients admitted for delivery at our department who requested postpartum contraception, were invited to participate in the study.
  • (2) Age (18-45)

You may not qualify if:

  • (1) Intrauterine infection at time of delivery (chorioamnionitis) (2) postpartum hemorrhage (3) Uterine anomalies (distorted uterine cavity) (4) History of previous IUD expulsion (5) Anemic patients with hemoglobin\< 10gm/dl (6) pre-labor rupture of membranes for more than 18 hours (7) Placenta previa.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, Egypt

Location

Related Publications (15)

  • Bilian X. Chinese experience with intrauterine devices. Contraception. 2007 Jun;75(6 Suppl):S31-4. doi: 10.1016/j.contraception.2006.12.007. Epub 2007 Feb 16.

    PMID: 17531613BACKGROUND

  • Hillard PJ. Practical tips for intrauterine devices use in adolescents. J Adolesc Health. 2013 Apr;52(4 Suppl):S40-6. doi: 10.1016/j.jadohealth.2012.09.023.

    PMID: 23535056BACKGROUND

  • Behtash N, Akhavan S, Mokhtar S. Pelvic mass due to transmigrated IUD. Acta Med Iran. 2010 Mar-Apr;48(2):125-6.

    PMID: 21133007BACKGROUND

  • Vasquez P, Schreiber CA. The missing IUD. Contraception. 2010 Aug;82(2):126-8. doi: 10.1016/j.contraception.2010.02.019. Epub 2010 Apr 2. No abstract available.

    PMID: 20654751BACKGROUND

  • Ko PC, Lin YH, Lo TS. Intrauterine contraceptive device migration to the lower urinary tract: report of 2 cases. J Minim Invasive Gynecol. 2011 Sep-Oct;18(5):668-70. doi: 10.1016/j.jmig.2011.05.010.

    PMID: 21872173BACKGROUND

  • Kus E, Swierczewski A, Pasinski J, Estemberg D, Brzozowska M, Kowalska-Koprek U, Berner-Trabska M, Karowicz-Bilinska A. [Intrauterine contraceptive device in an appendix--a case report]. Ginekol Pol. 2012 Feb;83(2):132-5. Polish.

    PMID: 22568359BACKGROUND

  • Taras AR, Kaufman JA. Laparoscopic retrieval of intrauterine device perforating the sigmoid colon. JSLS. 2010 Jul-Sep;14(3):453-5. doi: 10.4293/108680810X12924466006684.

    PMID: 21333209BACKGROUND

  • Vilallonga R, Rodriguez N, Vilchez M, Armengol M. Translocation of an intrauterine contraceptive device: incidental finding in the rectosigmoid colon. Obstet Gynecol Int. 2010;2010:404160. doi: 10.1155/2010/404160. Epub 2010 Jun 9.

    PMID: 20613996BACKGROUND

  • Koltan SO, Tamay AG, Yildirim Y. Chronic cervical perforation by an intrauterine device. J Chin Med Assoc. 2010 Jun;73(6):325-6. doi: 10.1016/S1726-4901(10)70069-1.

    PMID: 20603091BACKGROUND

  • American College of Obstetricians and Gynecologists' Committee on Obstetric Practice. Committee Opinion No. 670: Immediate Postpartum Long-Acting Reversible Contraception. Obstet Gynecol. 2016 Aug;128(2):e32-7. doi: 10.1097/AOG.0000000000001587.

    PMID: 27454734BACKGROUND

  • Whitaker AK, Chen BA. Society of Family Planning Guidelines: Postplacental insertion of intrauterine devices. Contraception. 2018 Jan;97(1):2-13. doi: 10.1016/j.contraception.2017.09.014. Epub 2017 Oct 5.

    PMID: 28987293BACKGROUND

  • Lopez LM, Bernholc A, Hubacher D, Stuart G, Van Vliet HA. Immediate postpartum insertion of intrauterine device for contraception. Cochrane Database Syst Rev. 2015 Jun 26;2015(6):CD003036. doi: 10.1002/14651858.CD003036.pub3.

    PMID: 26115018BACKGROUND

  • Averbach SH, Ermias Y, Jeng G, Curtis KM, Whiteman MK, Berry-Bibee E, Jamieson DJ, Marchbanks PA, Tepper NK, Jatlaoui TC. Expulsion of intrauterine devices after postpartum placement by timing of placement, delivery type, and intrauterine device type: a systematic review and meta-analysis. Am J Obstet Gynecol. 2020 Aug;223(2):177-188. doi: 10.1016/j.ajog.2020.02.045. Epub 2020 Mar 3.

    PMID: 32142826BACKGROUND

  • Nelson AL, Chen S, Eden R. Intraoperative placement of the Copper T-380 intrauterine devices in women undergoing elective cesarean delivery: a pilot study. Contraception. 2009 Jul;80(1):81-3. doi: 10.1016/j.contraception.2009.01.014. Epub 2009 Mar 4.

    PMID: 19501220BACKGROUND

  • Mosley FR, Shahi N, Kurer MA. Elective surgical removal of migrated intrauterine contraceptive devices from within the peritoneal cavity: a comparison between open and laparoscopic removal. JSLS. 2012 Apr-Jun;16(2):236-41. doi: 10.4293/108680812x13427982377265.

    PMID: 23477171BACKGROUND

MeSH Terms

Conditions

InfectionsInflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 21, 2022

First Posted

November 22, 2022

Study Start

October 22, 2022

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

November 22, 2022

Record last verified: 2022-11

Locations

EG(1)