Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00476021
Status:
COMPLETED
Last Update Posted:
2016-06-24
First Post:
2007-05-17
Brief Title:
Postplacental or Delayed Insertion of the Levonorgestrel-releasing Intrauterine Device IUD After Vaginal Delivery
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Randomized Trial of Postplacental or Delayed Insertion of the Levonorgestrel-releasing Intrauterine Device After Vaginal Delivery
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POPI
Brief Summary:
This study is a randomized controlled trial comparing 6 month usage rates of the levonorgestrel-releasing intrauterine device LNG-IUD when inserted postplacentally after vaginal delivery or delayed placement at 6-8 weeks postpartum Given the high rate of unintended pregnancy in the United States particularly in postpartum women there is a need for reliable effective long-term contraception such as the IUD in postpartum women Postplacental insertion of intrauterine contraception would help to address this need The primary hypothesis of this study is that use of the LNG-IUD at 6 months after vaginal delivery will be higher in women who have immediate postplacental insertion as compared to delayed insertion 6-8 weeks following delivery
Detailed Description:
The United States US has the highest unintended pregnancy rate of any developed country Of the 64 million pregnancies in the US each year almost half are unintended 49 Roughly half of these 22 of all pregnancies result in unintended births while 20 of all pregnancies result in abortion Postpartum women are particularly susceptible with an unintended pregnancy rate of 10-44 in the first year postpartum These unintended pregnancies occur despite the recommendation that a contraceptive method be selected prior to hospital discharge
Given the high rate of unintended pregnancy in the United States particularly in postpartum women there is a need for reliable effective long-term contraception such as the IUD in postpartum women Postplacental insertion of intrauterine contraception would help to address this need The IUD is a highly effective but underused method of postpartum contraception Although the expulsion rate in postplacental insertion is higher than interval insertion the benefits of highly effective contraception available immediately after delivery may outweigh the risks of expulsion
To date there have been no randomized trials of postplacental insertion of the LNG-IUD in the United States One pilot study in the United States of 20 subjects who received an ultrasound-guided postplacental insertion of the LNG-IUD showed an acceptable expulsion rate of 10 and no infections over a 10-week follow-up thus making postplacental insertion of LNG-IUD safe for further study
This study is a randomized controlled trial comparing 6 month usage rates of the levonorgestrel-releasing intrauterine device LNG-IUD when inserted postplacentally after vaginal delivery or delayed placement at 6-8 weeks postpartum One hundred sixty-eight women receiving prenatal care at Magee-Womens Hospital Pittsburgh PA who are interested in using the LNG-IUD for contraception will be enrolled during their pregnancy The IUD will be inserted within 10 minutes after delivery of the placenta in women randomized to immediate insertion Delayed IUD insertion will be performed at the first postpartum visit in 6-8 weeks All subjects will follow up in person at 6-8 weeks and 6 months after delivery A telephone interview will occur at 3 months after delivery for all subjects
Subjects who are not eligible for insertion due to post-randomization ineligibility criteria will be referred to their primary gynecologist or midwife for delayed IUD placement They will be contacted by phone at 3 and 6 months to assess quality of life contraceptive usage and unintended pregnancy rates
Given the high rate of unintended pregnancy in the United States particularly in postpartum women there is a need for reliable effective long-term contraception such as the IUD in postpartum women Postplacental insertion of intrauterine contraception would help to address this need The IUD is a highly effective but underused method of postpartum contraception Although the expulsion rate in postplacental insertion is higher than interval insertion the benefits of highly effective contraception available immediately after delivery may outweigh the risks of expulsion
To date there have been no randomized trials of postplacental insertion of the LNG-IUD in the United States One pilot study in the United States of 20 subjects who received an ultrasound-guided postplacental insertion of the LNG-IUD showed an acceptable expulsion rate of 10 and no infections over a 10-week follow-up thus making postplacental insertion of LNG-IUD safe for further study
This study is a randomized controlled trial comparing 6 month usage rates of the levonorgestrel-releasing intrauterine device LNG-IUD when inserted postplacentally after vaginal delivery or delayed placement at 6-8 weeks postpartum One hundred sixty-eight women receiving prenatal care at Magee-Womens Hospital Pittsburgh PA who are interested in using the LNG-IUD for contraception will be enrolled during their pregnancy The IUD will be inserted within 10 minutes after delivery of the placenta in women randomized to immediate insertion Delayed IUD insertion will be performed at the first postpartum visit in 6-8 weeks All subjects will follow up in person at 6-8 weeks and 6 months after delivery A telephone interview will occur at 3 months after delivery for all subjects
Subjects who are not eligible for insertion due to post-randomization ineligibility criteria will be referred to their primary gynecologist or midwife for delayed IUD placement They will be contacted by phone at 3 and 6 months to assess quality of life contraceptive usage and unintended pregnancy rates
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None