Trial Outcomes & Findings for Safety and Expulsion of Delayed Versus Immediate Postpartum Intrauterine Device Placement (NCT NCT01598662)

Results Overview

The investigators wanted to compare the expulsion rate of IUDs between the two treatment arms: immediate placement after placental delivery and interval placement 6 weeks after delivery. IUD expulsion is confirmed by the inability of the physician to visualize the string attached to the IUD coming from the cervix.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

6 months

Results posted on

2018-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	IUD Insertion 6 Weeks After Delivery Device:Levonorgestrel-releasing intrauterine device marketed as Mirena. Subjects randomized to interval placement will have their IUD placed in the office at six weeks postpartum or later. They must return for one visit within a month for a "string check"	Immediate Post-Placental Insertion Device: Levonorgestrel-releasing intrauterine device marketed as Mirena Subjects randomized to immediate post-placental placement within 10 minutes of delivery will have an IUD placed manually under sterile technique and with ultrasound guidance. An ultrasound will be performed within two days postpartum to verify proper placement and again at approximately six weeks postpartum
Overall Study STARTED	11	21
Overall Study Patients Who Received IUD	0	18
Overall Study Patients Returned for 6 wk Postpartum	0	2
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	11	21

Reasons for withdrawal

Reasons for withdrawal
Measure	IUD Insertion 6 Weeks After Delivery Device:Levonorgestrel-releasing intrauterine device marketed as Mirena. Subjects randomized to interval placement will have their IUD placed in the office at six weeks postpartum or later. They must return for one visit within a month for a "string check"	Immediate Post-Placental Insertion Device: Levonorgestrel-releasing intrauterine device marketed as Mirena Subjects randomized to immediate post-placental placement within 10 minutes of delivery will have an IUD placed manually under sterile technique and with ultrasound guidance. An ultrasound will be performed within two days postpartum to verify proper placement and again at approximately six weeks postpartum
Overall Study Lost to Follow-up	10	17
Overall Study Physician Decision	1	2
Overall Study IUD expelled before month 6	0	2

Baseline Characteristics

Safety and Expulsion of Delayed Versus Immediate Postpartum Intrauterine Device Placement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IUD Insertion 6 Weeks After Delivery n=11 Participants Subjects randomized to interval placement will have their IUD placed in the office at six weeks postpartum or later.	Immediate Post-placental Insertion n=21 Participants Subjects randomized to immediate post-placental placement within 10 minutes of delivery will have an IUD placed	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	21 Participants n=7 Participants	32 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	21 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	21 participants n=7 Participants	32 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 0 participants were evaluable in the Arm "IUD Insertion 6 Weeks After Delivery", as 0 participants received an IUD at 6 weeks, and 2 participants in the Arm "Immediate Post-placental Insertion" were evaluable, as there were only 2 participants that came back for a follow up appointment.

The investigators wanted to compare the expulsion rate of IUDs between the two treatment arms: immediate placement after placental delivery and interval placement 6 weeks after delivery. IUD expulsion is confirmed by the inability of the physician to visualize the string attached to the IUD coming from the cervix.

Outcome measures

Outcome measures
Measure	IUD Insertion 6 Weeks After Delivery Subjects randomized had their IUD placed in the office at six weeks postpartum or later.	Immediate Post-placental Insertion n=2 Participants Subjects randomized to immediate post-placental placement within 10 minutes of delivery had an IUD placed manually under sterile technique and with ultrasound guidance
IUD Expulsion Rate	0 Participants	2 Participants

Adverse Events

IUD Insertion 6 Weeks After Delivery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Immediate Post-placental Insertion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nancy Alsip

University Louisville

Phone: 502-852-2905

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place