Monitoring With Ultrasound Imaging of Intrauterine Device (IUD) Position Placed Immediately After Giving Birth
| Status: | Completed |
|---|---|
| Conditions: | Contraception, Contraception |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 10/13/2017 |
| Start Date: | December 2013 |
| End Date: | September 15, 2017 |
Ultrasound Surveillance of IUDs Placed Immediately Postpartum
Intrauterine devices (IUDs) are one of the most effective reversible forms of contraception,
and are a good option in the postpartum period for women to avoid a rapid repeat pregnancy.
IUDs can be placed immediately postpartum, after delivery of the placenta by either vaginal
or cesarean birth. This practice has been shown to be safe, and is recommended by the
American College of Obstetricians & Gynecologists, the World Health Organization and the U.S.
Center for Disease Control. Immediate postpartum IUD placement has the advantage of providing
contraception at a time that the woman is already accessing medical care, avoiding potential
loss to follow up or risk of unintended pregnancy. Additionally, women who have anesthesia
for delivery have reduced pain at the time of IUD placement compared to having the IUD placed
at the postpartum follow up appointment. Immediate postpartum IUD placement is a relatively
new practice in the US and little is known about the expected appearance of IUDs inside the
uterus taken with an ultrasound when they have been placed at the time of delivery. It is
less likely that IUD strings will be visible at the cervix after immediate postpartum IUD
placement due to subsequent uterine involution, which makes it important to monitor correct
positioning of the IUD via ultrasound. This study will document normal changes in the
positioning of the IUD visualized via ultrasound, and determine if a correlation exists
between IUD position and risk of expulsion. Ultrasound surveillance to document IUD position
and distance from the fundus, will be performed at 6 weeks, 3 months and 12 months after
placement. Symptoms of menstrual bleeding and pain will also be recorded in order to
determine if they are correlated with IUD position.
and are a good option in the postpartum period for women to avoid a rapid repeat pregnancy.
IUDs can be placed immediately postpartum, after delivery of the placenta by either vaginal
or cesarean birth. This practice has been shown to be safe, and is recommended by the
American College of Obstetricians & Gynecologists, the World Health Organization and the U.S.
Center for Disease Control. Immediate postpartum IUD placement has the advantage of providing
contraception at a time that the woman is already accessing medical care, avoiding potential
loss to follow up or risk of unintended pregnancy. Additionally, women who have anesthesia
for delivery have reduced pain at the time of IUD placement compared to having the IUD placed
at the postpartum follow up appointment. Immediate postpartum IUD placement is a relatively
new practice in the US and little is known about the expected appearance of IUDs inside the
uterus taken with an ultrasound when they have been placed at the time of delivery. It is
less likely that IUD strings will be visible at the cervix after immediate postpartum IUD
placement due to subsequent uterine involution, which makes it important to monitor correct
positioning of the IUD via ultrasound. This study will document normal changes in the
positioning of the IUD visualized via ultrasound, and determine if a correlation exists
between IUD position and risk of expulsion. Ultrasound surveillance to document IUD position
and distance from the fundus, will be performed at 6 weeks, 3 months and 12 months after
placement. Symptoms of menstrual bleeding and pain will also be recorded in order to
determine if they are correlated with IUD position.
The goal of this study is to document the expected ultrasound appearance of intrauterine
devices (IUDs) placed immediately postpartum. This practice has been shown to be safe and
effective, but little is known about long-term follow up for IUDs placed in this setting.
Because IUD strings will not be visualized for many patients after immediate postpartum IUD
placement, sonographic imaging will likely be required for the majority of patients to
determine expulsion. However, the ultrasound appearance of these IUDs, placed immediately
after birth and before uterine involution, may be different than those IUDs placed outside of
the postpartum period. To our knowledge no other study has documented expected ultrasound
appearance of IUDs placed in the immediate postpartum period.
The specific aims of this study are to: 1. document normal appearance of IUDs on ultrasound
after immediate postpartum placement; 2. document if this appearance changes over time; and
3. determine if location on ultrasound is associated with side effects or expulsion.
Study design This is a prospective, observational study. All patients who have an IUD (either
copper or levonorgestrel) placed immediately postpartum (within 10 minutes of delivery of
placenta) after either Cesarean or vaginal delivery at Mount Sinai Medical Center and at
Elmhurst Hospital Center will be eligible to participate in the study.
Study visits will include a speculum exam for IUD string check at 6 weeks, and ultrasounds to
evaluate IUD position at the following time points: 6-10 weeks following placement, 3 months
following placement (with inclusion up to 6 months), and 12 months following placement (with
inclusion up to 15 months).
The ultrasound will document the following: size and position of uterus, IUD-Myometrium
distance, IUD-endometrium distance, IUD-fundus distance and position of IUD. When
participants present for the scheduled ultrasound visits, they will be asked to return with
the completed symptom diary as well, to assess bleeding and pain.
Study Endpoints IUD expulsion, removal, or completion of the 12-15 month follow up visit will
be the study endpoints. The participant will be withdrawn from the study if IUD expulsion
occurs, or if she requests IUD removal for any reason. Participants will also be able to
withdraw from the study at any time if they no longer wish to participate, but they may keep
their IUD in place if desired.
Study procedures At the routine 6 week postpartum visit for all patients, pelvic and speculum
exam will be performed as per normal clinical routine, and visualization of IUD strings at
the cervical os will be documented. If IUD strings are not visualized, an ultrasound will be
performed by the clinical provider to confirm presence or absence of IUD within the uterus.
A formal ultrasound to evaluate IUD position will be scheduled in the FPA gynecologic
ultrasound unit or in the Gynecology clinic at EHC at the following time points: 6-10 weeks
following placement, 3 months following placement (with inclusion up to 6 months), and 12
months following placement (with inclusion up to 15 months). The formal ultrasound will
document the following: size and position of uterus, endometrial stripe (EMS) thickness,
IUD-Myometrium distance, IUD-endometrium distance, IUD-fundus distance and position of IUD.
Immediate postpartum placement of IUDs is a relatively new clinical practice in the United
States; as such there is no recommended or "standard" follow up protocol in this situation.
For IUDs placed outside of the postpartum period, the standard follow up is a string check
(speculum exam to confirm presence of strings at cervical os) 2-6 weeks after IUD placement.
If strings are not visible, or if the patient experiences symptoms concerning for expulsion,
a transvaginal ultrasound will be performed. Once correct placement is confirmed by
ultrasound, patients without visible strings generally have ultrasounds yearly to confirm
placement. Based on this standard practice, patients with visible strings will have the
ultrasound only for research purposes. Additionally, the three month ultrasound will be only
for research purposes, even in those without visible strings.
When participants present for the scheduled ultrasound visits, they will be asked to return
with the completed symptom diary as well.
devices (IUDs) placed immediately postpartum. This practice has been shown to be safe and
effective, but little is known about long-term follow up for IUDs placed in this setting.
Because IUD strings will not be visualized for many patients after immediate postpartum IUD
placement, sonographic imaging will likely be required for the majority of patients to
determine expulsion. However, the ultrasound appearance of these IUDs, placed immediately
after birth and before uterine involution, may be different than those IUDs placed outside of
the postpartum period. To our knowledge no other study has documented expected ultrasound
appearance of IUDs placed in the immediate postpartum period.
The specific aims of this study are to: 1. document normal appearance of IUDs on ultrasound
after immediate postpartum placement; 2. document if this appearance changes over time; and
3. determine if location on ultrasound is associated with side effects or expulsion.
Study design This is a prospective, observational study. All patients who have an IUD (either
copper or levonorgestrel) placed immediately postpartum (within 10 minutes of delivery of
placenta) after either Cesarean or vaginal delivery at Mount Sinai Medical Center and at
Elmhurst Hospital Center will be eligible to participate in the study.
Study visits will include a speculum exam for IUD string check at 6 weeks, and ultrasounds to
evaluate IUD position at the following time points: 6-10 weeks following placement, 3 months
following placement (with inclusion up to 6 months), and 12 months following placement (with
inclusion up to 15 months).
The ultrasound will document the following: size and position of uterus, IUD-Myometrium
distance, IUD-endometrium distance, IUD-fundus distance and position of IUD. When
participants present for the scheduled ultrasound visits, they will be asked to return with
the completed symptom diary as well, to assess bleeding and pain.
Study Endpoints IUD expulsion, removal, or completion of the 12-15 month follow up visit will
be the study endpoints. The participant will be withdrawn from the study if IUD expulsion
occurs, or if she requests IUD removal for any reason. Participants will also be able to
withdraw from the study at any time if they no longer wish to participate, but they may keep
their IUD in place if desired.
Study procedures At the routine 6 week postpartum visit for all patients, pelvic and speculum
exam will be performed as per normal clinical routine, and visualization of IUD strings at
the cervical os will be documented. If IUD strings are not visualized, an ultrasound will be
performed by the clinical provider to confirm presence or absence of IUD within the uterus.
A formal ultrasound to evaluate IUD position will be scheduled in the FPA gynecologic
ultrasound unit or in the Gynecology clinic at EHC at the following time points: 6-10 weeks
following placement, 3 months following placement (with inclusion up to 6 months), and 12
months following placement (with inclusion up to 15 months). The formal ultrasound will
document the following: size and position of uterus, endometrial stripe (EMS) thickness,
IUD-Myometrium distance, IUD-endometrium distance, IUD-fundus distance and position of IUD.
Immediate postpartum placement of IUDs is a relatively new clinical practice in the United
States; as such there is no recommended or "standard" follow up protocol in this situation.
For IUDs placed outside of the postpartum period, the standard follow up is a string check
(speculum exam to confirm presence of strings at cervical os) 2-6 weeks after IUD placement.
If strings are not visible, or if the patient experiences symptoms concerning for expulsion,
a transvaginal ultrasound will be performed. Once correct placement is confirmed by
ultrasound, patients without visible strings generally have ultrasounds yearly to confirm
placement. Based on this standard practice, patients with visible strings will have the
ultrasound only for research purposes. Additionally, the three month ultrasound will be only
for research purposes, even in those without visible strings.
When participants present for the scheduled ultrasound visits, they will be asked to return
with the completed symptom diary as well.
Inclusion Criteria:
- Women >18 years of age
- English or Spanish speaking
- Desire postpartum IUD placement, either copper IUD or levonorgestrel IUD
Exclusion Criteria:
- Contraindications for IUD use (CDC MEDICAL Eligibility Criteria category 3 or 4 for
specific IUD)
- Positive Chlamydia or gonorrhea cervical cultures in past 3 months
- Immediate postpartum hemorrhage
- Premature rupture of membranes (PROM) >12h or diagnosis of endometritis
We found this trial at
2
sites
1428 Madison Ave
New York, New York 10029
New York, New York 10029
(212) 241-6500
Principal Investigator: Britt Lunde, MD, MPH
Phone: 917-446-4659
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
Click here to add this to my saved trials
Elmhurst, New York 11373
Principal Investigator: Britt Lunde, MD, MPH
Phone: 917-446-4659
Click here to add this to my saved trials