Contraception Behavior
Conditions
Keywords
IUD, Second trimester termination, Contraception
Brief summary
The purpose of this study is to compare delayed vs. immediate insertion of the Copper T 380 IUD after termination of pregnancy after 12 weeks.
Detailed description
Patients presenting to ParkMed Women's Clinic and the Reproductive Choice clinic at Bellevue Hospital for second trimester termination will be offered participation in this study. They will be randomized to either delayed or immediate Copper T 380A IUD insertion. The subjects will be seen at a 6 month follow-up visit and Copper T 380A IUD placement will be verified by physical exam. At this 6 month follow-up visit, subjects will fill out a satisfaction questionnaire.
Interventions
DEVICECopper T 380A IUD
Copper T 380A IUD will be placed at the 2-4 week post-operative visit.
Sponsors
Icahn School of Medicine at Mount Sinai
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* women 16 years of age and older * intrauterine pregnancy \> 14 weeks gestation * desires termination of pregnancy * desires IUD for contraception * ability to give informed consent * no contraindication for D+E
Exclusion criteria
* unable to give informed consent * less than 16 years of age * congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity * acute pelvic inflammatory disease (PID) * known or suspected uterine or cervical neoplasia or unresolved abnormal PAP smear * untreated acute cervicitis or vaginitis, until infection treated/controlled * confirmed Chlamydia trachomatis or Neisseria gonorrhea infection in the previous 90 days * acute liver disease or liver tumor (benign or malignant) * woman or partner currently with multiple sexual partners * history of Wilson's disease * hypersensitivity to any component of Copper T IUD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use of IUD | 6 months | Number of participants using Copper T380A IUD 6 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Expulsion | 6 months | IUD was not removed by provider but fell out on its own. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| A/Immediate The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure
Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure. | 104 |
| B/Delayed The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.
Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit. | 111 |
| Total | 215 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 33 | 23 |
Baseline characteristics
| Characteristic | A/Immediate | B/Delayed | Total |
|---|---|---|---|
| Age, Continuous | 24 years | 23.4 years | 23.7 years |
| Gestational age | 19.2 weeks | 18.8 weeks | 19.0 weeks |
| Race/Ethnicity, Customized Asian or South Asian | 1 participants | 4 participants | 5 participants |
| Race/Ethnicity, Customized Black | 48 participants | 52 participants | 100 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 43 participants | 39 participants | 82 participants |
| Race/Ethnicity, Customized Missing | 2 participants | 2 participants | 4 participants |
| Race/Ethnicity, Customized Mixed | 4 participants | 5 participants | 9 participants |
| Race/Ethnicity, Customized Other | 2 participants | 3 participants | 5 participants |
| Race/Ethnicity, Customized White | 4 participants | 6 participants | 10 participants |
| Sex/Gender, Customized Female | 104 participants | 111 participants | 215 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 104 | 0 / 111 |
| serious Total, serious adverse events | 0 / 104 | 0 / 111 |
Outcome results
Primary
Use of IUD
Number of participants using Copper T380A IUD 6 months after surgery
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A/Immediate | Use of IUD | 58 participants |
| B/Delayed | Use of IUD | 25 participants |
Secondary
Expulsion
IUD was not removed by provider but fell out on its own.
Time frame: 6 months
Population: The analysis here includes the 64/71 A/Immediate arm and 26/88 B/Delayed arm who received an IUD. In the A/Immediate arm, 5 women changed their mind post-randomization and in 2 cases, the provider chose not to place it. In the B/Delayed arm, reasons included not returning for follow-up visit, changing mind, and provider not wanting to place IUD.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A/Immediate | Expulsion | 3.1 percentage of expulsions |
| B/Delayed | Expulsion | 0 percentage of expulsions |