Immediate Versus Delayed IUD Insertion After Second Trimester Medical Abortion

NCT03505047 — Not applicable, Completed, 110 participants, University of Cape Town

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

Registry	NCT03505047
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	110 (Actual)
Sponsor	University of Cape Town (Other); collaborators: University of California, San Francisco
Conditions	Contraception
Interventions	Copper Intrauterine device (Device)
Dates	start 2018-05-10, primary completion 2019-08-31, completion 2020-01-31, first posted 2018-04-23, last updated 2020-03-26
Locations	1 site in South Africa

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Immediate group:	Experimental	Device: Copper Intrauterine device	The Copper Intrauterine device will be inserted within 24 hours of the expulsion of the fetus and placenta or after surgical evacuation for placental remains, and prior to discharge from the facility.
Delayed Group	No intervention		The Copper Intrauterine device will be inserted at a local community health centre 14-28 days after discharge.

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

+Outcome measures

Primary outcomes

Use of the copper IUD [6 weeks after second trimester abortion]: Number of women using the IUD
Insertion of the IUD [6 weeks after second trimester abortion]: Number of IUD insertions

Secondary outcomes

Use of the IUD at 3 months post-abortion [3 months after second trimester medical abortion]: Number of women using the IUD
Use of the IUD at 6 months post-abortion [6 months after second trimester medical abortion]: Number of women using the IUD
Spontaneous expulsion of the IUD [6 weeks post-abortion]: Number of full and partial expulsions
Spontaneous expulsion of the IUD [Between 6 weeks and 3 months post abortion]: Number of full and partial expulsions
Spontaneous expulsion of the IUD [Between 3 and 6 months post abortion]: Number of full and partial expulsions
Removal of IUD and associated factors [within 3 and 6 months post-abortion]: Number of removals
Abortion-related and IUD-related complications [within 3 months post-abortion]: Number of complications
Women's satisfaction and acceptability of the IUD [Reported at 3 and 6 months post-abortion]: 5 point scales
Recurrent pregnancy [At 6 months post-abortion]: Number of recurrent pregnancies

+Eligibility

Sex: Female, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Groote Schuur Hospital	Cape Town, Western Province	South Africa

+Investigators

Deborah Constant, PhD, Principal investigator, University of Cape Town

My Notes

Public

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