Comparison of the Levonorgestrel IUD and the Copper IUD Placed in the Immediate Postplacental Period: A Prospective Cohort Study
| Status: | Completed |
|---|---|
| Conditions: | Contraception, Contraception |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/21/2016 |
| Start Date: | April 2014 |
| End Date: | September 2015 |
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.
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.
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
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