Immediate Versus Delayed IUD Insertion After Second Trimester Medical Abortion

Contraception Clinical Trial

Official title:

Immediate Versus Delayed Insertion of the Copper IUD After Second-trimester Medical Abortion - a Randomised Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03505047
• Other study ID #: 007/2018
• Status: Completed
• Phase: N/A
• Start date: May 10, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: March 2020
• Source: University of Cape Town
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of the study is to compare use, in a randomised controlled trial, of the the copper IUD if inserted immediately after completion of a second trimester medical abortion, to standard care with insertion 3-4 or more weeks after abortion at community health centres.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 31, 2020
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to speak English, Afrikaans or Xhosa;

• Requesting and eligible for abortion according to standard practice at the hospital;

• Gestational age 13-20 weeks verified by ultrasound;

• Interested and eligible for the copper IUD as a post-abortion contraceptive method;

• Willingness to participate in the trial including follow-up;

• Able to provide a working phone & telephone number to allow for contact;

• Willing and able to provide informed consent

• Staying within one hour travel time of GSH

Exclusion Criteria:

• Active pelvic inflammatory disease, pelvic tuberculosis; severe thrombocytopenia;

• Positive N. Gonorrhea or C. Trachomatis that has not been adequately treated

• Copper allergy

• Hb <10g/dL

• Uterine anomaly preventing placement of the IUD; cervical cancer or carcinoma in-situ, untreated high grade squamous intraepithelial lesions

• Hemorrhage; or ruptured uterus

• History of ectopic pregnancy

• Wilsons' disease

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• Copper Intrauterine device
Immediate insertion of the copper intrauterine device after completion of abortion

Locations

Country	Name	City	State
South Africa	Groote Schuur Hospital	Cape Town	Western Province

Sponsors (2)

Lead Sponsor	Collaborator
University of Cape Town	University of California, San Francisco

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of the copper IUD	Number of women using the IUD	6 weeks after second trimester abortion
Primary	Insertion of the IUD	Number of IUD insertions	6 weeks after second trimester abortion
Secondary	Use of the IUD at 3 months post-abortion	Number of women using the IUD	3 months after second trimester medical abortion
Secondary	Use of the IUD at 6 months post-abortion	Number of women using the IUD	6 months after second trimester medical abortion
Secondary	Spontaneous expulsion of the IUD	Number of full and partial expulsions	6 weeks post-abortion
Secondary	Spontaneous expulsion of the IUD	Number of full and partial expulsions	Between 6 weeks and 3 months post abortion
Secondary	Spontaneous expulsion of the IUD	Number of full and partial expulsions	Between 3 and 6 months post abortion
Secondary	Removal of IUD and associated factors	Number of removals	within 3 and 6 months post-abortion
Secondary	Abortion-related and IUD-related complications	Number of complications	within 3 months post-abortion
Secondary	Women's satisfaction and acceptability of the IUD	5 point scales	Reported at 3 and 6 months post-abortion
Secondary	Recurrent pregnancy	Number of recurrent pregnancies	At 6 months post-abortion