Abortion, Induced
Conditions
Keywords
second trimester abortion, labor induction abortion, second trimester medical abortion, pregnancy
Brief summary
One the day prior to medical abortion (labor induction) in the second trimester, insertion of osmotic dilators is added to the routine procedures. The study is to see whether the addition of dilators decreases the abortion time (time for the pregnancy to be expelled)
Detailed description
This is a pilot study and is an uncontrolled, non-randomized series. Women having a medical abortion in second trimester undergo several procedures the day before the medication to cause contractions occurs. On the day before admission, they take mifepristone orally, and have a feticidal injection. to this would be added the insertion of cervical osmotic dilators (the intervention). On the day of induction, the dilators would be removed and misoprostol started to cause contractions. We are hoping the median abortion time will drop from the present 9-10 hours to 4-6 hours. women who do not abort in 6 hours will have option of surgical completion of the abortion (dilation and evacuation) if medically appropriate.
Interventions
osmotic dilators are placed in the cervix to cause cervical dilation
Sponsors
Boston University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Requesting abortion 19-23 weeks * No contraindication to induction abortion
Exclusion criteria
* Fetal demise * Ruptured membranes * Evidence of pelvic infection * Inability to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Medical Abortion | hours since the start of medical abortion | This is the time elapsed from the first dose of misoprostol (the agent to induce abortion) and expulsion of the fetus |
Countries
United States
Participant flow
Recruitment details
Women requesting abortion at 19-23 weeks were eligible to enroll if they were able to consent and had no contraindications to medical abortion. Women were informed of the study after all counseling for abortion was completed and after they had given consent for abortion
Pre-assignment details
Women were eligible for study intervention if they had singleton pregnancy with intact membranes, without signs of infection.
Participants by arm
| Arm | Count |
|---|---|
| Osmotic Dilator osmotic dilator | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Osmotic Dilator |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age Continuous | 27 years STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Length of Medical Abortion
This is the time elapsed from the first dose of misoprostol (the agent to induce abortion) and expulsion of the fetus
Time frame: hours since the start of medical abortion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Osmotic Dilator | Length of Medical Abortion | 7 hours | Standard Deviation 5 |