Comparison of the Levonorgestrel IUD and the Copper IUD Placed in the Immediate Postplacental Period: A Prospective Cohort Study

Contraception Clinical Trial

Official title:

Comparison of the Levonorgestrel IUD and the Copper IUD Placed in the Immediate Postplacental Period: A Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02067663
• Other study ID #: 13-3264
• Status: Completed
• Start date: April 2014
• Est. completion date: September 2015

Study information

• Verified date: June 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The intrauterine device (IUD) is a safe, highly effective, long acting, and reversible form of contraception. The postpartum period is an important moment for contraceptive intervention; however there are many barriers to women obtaining birth control postpartum. The use of the IUD in the immediate postpartum setting offers many advantages and is considered safe, but the risk of expulsion appears to be higher than with interval insertion. Previous studies have shown the rate of expulsion of the copper IUD in the postplacental period to be in the range of 1-14% by 6-12 months, while the only study of the levonorgestrel IUD in the postplacental period documented a rate of expulsion of 24% by 12 months. While studies related to the copper IUD use ring forceps or the operator's hand for placement of the IUD, the only published study investigating immediate postplacental levonorgestrel IUD insertion utilized the manufacturer's inserter for IUD placement. The investigators therefore ask the question, is there a difference in expulsion rates between levonorgestrel and copper IUDs placed post-placentally when all providers undergo a standardized training, use a standardized insertion technique, and when patient level characteristics are controlled by randomization?

The investigators propose to perform a prospective cohort trial comparing the rates of expulsion for the levonorgestrel and the copper IUD by 3 months postpartum when placed in the uterus within 10 minutes of the delivery of the placenta, using a standardized technique (placement with a ring forceps or the operator's hand) after all providers undergo a formal didactic and skills training. The investigators hypothesis is that the levonorgestrel IUD has a higher rate of expulsion as compared to the copper IUD. Additional objectives include a comparison of the rates of complete IUD expulsion, partial IUD expulsion, unrecognized expulsions, complications, IUD continuation, pregnancy, and satisfaction. Additionally, the investigators will document the natural history of the location of the IUD within the uterus when placed in the immediate postpartum period, utilizing ultrasound at 24 hours, 6 weeks, and 3 months postpartum, to better understand the relationship between position of the IUD and subsequent expulsion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Women age = 18

• Desire for immediate postpartum IUD or postpartum day #1 after a postplacental IUD placement

• English or Spanish speaking

• Willing to attend 2 follow-up visits

Exclusion Criteria:

• Multiple gestations

• Delivery prior to 35 weeks gestational age

• Allergy or sensitivity to any component of either IUD (including polyethylene, levonorgestrel or copper)

• Cesarean delivery

• Postpartum hemorrhage (estimated blood loss > 500 mL)

• Chorioamnionitis

• Abnormal uterine anatomy (including uterine anomaly or large fibroids)

• Treated for Chlamydia or Gonorrhea during pregnancy without a subsequent negative follow-up test

• Current cervical cancer or carcinoma in situ

• Current breast cancer

• Wilson's disease

• If enrolling postpartum after IUD has already been placed, women will be excluded if the provider used an insertion technique other than using the ring forceps or the operator's hand

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• Paragard
The IUD will be placed as part of standard clinical care.

Drug:
• Mirena
The IUD will be placed as part of standard clinical care.

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Society of Family Planning

Country where clinical trial is conducted

United States, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IUD Expulsion Rate	The primary outcome of the study is the total number of expulsions in the full 3 month study period. The provider will perform a speculum exam and transvaginal ultrasound. If expulsion has occurred, the participant will have an abdominal x-ray to confirm.	3 months postpartum
Secondary	Pregnancy	A urine pregnancy test will be performed at the 6 week follow up visit if clinically indicated.	6 weeks
Secondary	Pregnancy	A urine pregnancy test will be performed at the 3 month follow up visit if clinically indicated.	3 months
Secondary	Complications	A questionnaire will be administered to determine if the participant has had any complications since placement. Number of women reporting complications are reported.	3 months
Secondary	Satisfaction	A questionnaire will be administered to determine the participant's satisfaction level with the IUD. Satisfaction levels of >= 8 are reported by percent of participants.	3 months
Secondary	Intrauterine Device Expulsion (Day 1)	Number of expulsions at Day 1. Position of the IUD within the uterus will be documented by ultrasound.	Day 1
Secondary	Intrauterine Device Expulsion (6 Weeks)	Number of expulsions. Position of the IUD within the uterus will be documented by ultrasound.	6 weeks
Secondary	Intrauterine Device Expulsion by 12 Weeks Postpartum	Position of the IUD within the uterus will be documented by ultrasound.	12 weeks