Therapeutic Abortion
Conditions
Keywords
Misoprostol administration & dosage, Abortion techniques, Abortion Induced methods, Dilatation and Curettage
Brief summary
Cervical preparation before second trimester dilation and evacuation (D&E) reduces risks and complications. Osmotic cervical dilators as well as prostaglandin analogues have been studied for cervical preparation. However, the optimal method for cervical preparation, especially for D&E procedures that occur on the same day as cervical preparation, is not known. This study will investigate misoprostol versus placebo as an adjunct to Dilapan-S for cervical preparation for same-day D&E between 16+0 and 20+6 weeks gestation. HYPOTHESIS: Administration of 400 µg buccal misoprostol compared to placebo at least 3 hours prior to D&E as an adjunct to cervical preparation with Dilapan-S will decrease operative time for same-day D&E performed between 16+0 and 20+6 weeks.
Detailed description
Dilation and evacuation (D&E) is commonly performed for second trimester abortions and management of second trimester intrauterine fetal demise (IUFD). Cervical preparation prior to second trimester D&E increases safety. Osmotic cervical dilators and prostaglandin analogs are used widely for cervical preparation before second trimester D&E. Osmotic dilators are placed into the cervical canal, radially expand as they absorb moisture and decrease the risk of cervical injury during D&E. Laminaria tents are the most commonly used osmotic dilator for D&E cervical preparation but require N18 h to reach maximum diameter. Dilapan-S®, a synthetic osmotic cervical dilator, has a significant dilation effect 2 h after placement with the majority of expansion occurring in 4-6 h according to the manufacturer. Misoprostol is the most commonly used pharmacologic cervical preparation for D&E with duration of action between 2 and 4 h after administration. Multiple studies demonstrate the safety of misoprostol before early second trimester abortion. One prospective and four retrospective studies suggest that same-day cervical preparation with Dilapan-S and/or misoprostol for second trimester D&E through 20 weeks is safe and effective. Misoprostol may be less effective when used alone compared to overnight osmotic dilators for cervical preparation later in the second trimester but has adjunctive benefit on cervical dilation and procedure time when used with overnight osmotic dilators between 16 and 24 weeks. The effect appears most pronounced at N19 weeks gestation. No prospective studies have been published examining misoprostol as an adjunct to osmotic dilators for cervical preparation for same-day D&E. Administration of adjunctive misoprostol with Dilapan-S has the potential to effectively prepare the cervix and decrease operative time for same-day D&E. We compared cervical preparation with Dilapan-S with and without adjunctive buccal misoprostol for same-day D&E between 16 0/7 and 20 6/7 weeks gestation.
Interventions
DRUGMisoprostol
400 mcg of buccal misoprostol, 3 hours prior to planned D&E
DRUGFolic Acid
4 mg of buccal folic acid, 3 hours prior to planned D&E
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age greater than or equal to 18 years (no upper age limit) * Gestational age between 16+0 and 20+6 weeks gestation on day of D&E with confirmation of gestational age by ultrasound * Desires D&E for termination of pregnancy or for fetal demise * Able to provide written informed consent * Able to comply with study procedures * English-speaking
Exclusion criteria
* Known allergy or contraindication to misoprostol * Pregnancy with a multiple gestation * Known bleeding disorder or current anticoagulation therapy (within one month of procedure) * Active bleeding or hemodynamically unstable at enrollment * Signs of chorioamnionitis or clinical infection at enrollment * Signs of spontaneous labor or cervical insufficiency at enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time | Day 1 of the study | The primary outcome will be operative time. Operative time will be measured from initial passage of an instrument into the uterus to start the D&E. The end of operative time will be measured by the removal of the last instrument from the uterus to complete the D&E. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Pain | Day 1 | Change in pain from baseline to immediately preoperatively using a 100-mm Visual Analogue Scale (100-mm Visual Analogue Scale with 0 indicating no pain and 100 indicating worst pain in my life) |
| Number of Participants With Postoperative Satisfaction | Day 1 | Patient postoperative satisfaction with cervical preparation method |
| Number of Providers With Overall Satisfaction | Day 1 | Provider overall satisfaction with cervical preparation |
| Complications | Day 1 | Incidence of surgical complications related to D&E |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Misoprostol Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.
Misoprostol | 14 |
| Folic Acid Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S
Folic Acid | 15 |
| Total | 29 |
Baseline characteristics
| Characteristic | Misoprostol | Folic Acid | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 15 Participants | 29 Participants |
| Gender Female | 14 Participants | 15 Participants | 29 Participants |
| Gender Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 15 |
| serious Total, serious adverse events | 0 / 14 | 2 / 15 |
Outcome results
Primary
Operative Time
The primary outcome will be operative time. Operative time will be measured from initial passage of an instrument into the uterus to start the D&E. The end of operative time will be measured by the removal of the last instrument from the uterus to complete the D&E.
Time frame: Day 1 of the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Misoprostol | Operative Time | 11.1 minutes | Standard Deviation 5.4 |
| Folic Acid | Operative Time | 13.5 minutes | Standard Deviation 4 |
p-value: 0.17t-test, 2 sided
Secondary
Complications
Incidence of surgical complications related to D&E
Time frame: Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Misoprostol | Complications | 0 participants |
| Folic Acid | Complications | 2 participants |
Secondary
Number of Participants With Postoperative Satisfaction
Patient postoperative satisfaction with cervical preparation method
Time frame: Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Misoprostol | Number of Participants With Postoperative Satisfaction | 10 participants |
| Folic Acid | Number of Participants With Postoperative Satisfaction | 14 participants |
Secondary
Number of Providers With Overall Satisfaction
Provider overall satisfaction with cervical preparation
Time frame: Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Misoprostol | Number of Providers With Overall Satisfaction | 10 providers |
| Folic Acid | Number of Providers With Overall Satisfaction | 9 providers |
Secondary
Patient Pain
Change in pain from baseline to immediately preoperatively using a 100-mm Visual Analogue Scale (100-mm Visual Analogue Scale with 0 indicating no pain and 100 indicating worst pain in my life)
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Misoprostol | Patient Pain | 43.9 mm | Standard Deviation 25.4 |
| Folic Acid | Patient Pain | 24.3 mm | Standard Deviation 26.4 |
p-value: 0.052t-test, 2 sided