Clinical trial NCT03505047: Immediate Versus Delayed IUD Insertion After Second Trimester Medical Abortion
Official title: Immediate Versus Delayed Insertion of the Copper IUD After Second-trimester Medical Abortion - a Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: second trimester medical abortion
Immediate versus delayed insertion
copper intrauterine device
Lead sponsor: University of Cape Town
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2018-04-23
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Use of the copper IUD
timeFrame: 6 weeks after second trimester abortion
measure: Insertion of the IUD
timeFrame: 6 weeks after second trimester abortion
Secondary outcomes:
measure: Use of the IUD at 3 months post-abortion
timeFrame: 3 months after second trimester medical abortion
measure: Use of the IUD at 6 months post-abortion
timeFrame: 6 months after second trimester medical abortion
measure: Spontaneous expulsion of the IUD
timeFrame: 6 weeks post-abortion
measure: Spontaneous expulsion of the IUD
timeFrame: Between 6 weeks and 3 months post abortion
measure: Spontaneous expulsion of the IUD
timeFrame: Between 3 and 6 months post abortion
measure: Removal of IUD and associated factors
timeFrame: within 3 and 6 months post-abortion
measure: Abortion-related and IUD-related complications
timeFrame: within 3 months post-abortion
measure: Women's satisfaction and acceptability of the IUD
timeFrame: Reported at 3 and 6 months post-abortion
measure: Recurrent pregnancy
timeFrame: At 6 months post-abortion
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
state: Western Province
Study officials:
affiliation: University of Cape Town
name: Deborah Constant, PhD
role: PRINCIPAL_INVESTIGATOR
References: