Second Trimester Abortion
Conditions
Keywords
abortion, cervical dilation
Brief summary
Primary objective: To study the difference in dilation and evacuation (D&E) procedure time following overnight cervical preparation with laminaria or Dilapan-S™. The investigators hypothesize procedure time will be less with Dilapan-S™. Secondary objectives: To compare the use of laminaria and Dilapan-S™ for differences in: (1) initial cervical dilation before D&E; (2) need for mechanical dilation to accomplish D&E and ease of dilation if required; (3) number of osmotic dilators placed; (4) ability to complete the D&E procedure without further cervical preparation; (5) complications; (6) pain and other side effects; (7) patient acceptability; and (8) provider acceptability.
Detailed description
One hundred eighty women were randomized evenly across treatment arms, stratified by gestational age groups of 18 0/7-20 6/7 (n= 91) and 21 0/7-24 0/7 (n=87). The analytic sample N=173 (laminaria=86, Dilapan=87); 2 cases were removed for post-randomization exclusion and 5 for missing data on one or more outcome variables. Demographic information and results for the primary outcome of procedure time are reported below in tabular form in the results section.
Sponsors
Society of Family Planning
Planned Parenthood of Greater New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age and older * Seeking pregnancy termination from 18 0/7 to 24 0/7 weeks of gestation * Eligible for pregnancy termination at Planned Parenthood of New York City * Able to give informed consent * English speaking
Exclusion criteria
* • Active bleeding or hemodynamically unstable at enrollment * Signs of chorioamnionitis or clinical infection at enrollment * Signs of spontaneous labor or cervical insufficiency at enrollment * Spontaneous intrauterine fetal demise * Allergy to laminaria or Dilapan-S™
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| D&E Procedure Time | The primary outcome measure will be assessed on the day of the patient's D&E procedure. (day 2) | Length of D&E procedure in minutes |
Countries
United States
Participant flow
Recruitment details
Eligible patients identified during surgical abortion services by tracking gestational age using electronic health record. Patients seeking abortion services undergo standard clinical procedures for pre-operative evaluation, and routine abortion counselling and surgical consent. After clinic staff confirmed patient is eligibility, research staff tell her about the study and, if the patient is interested in study participation, screen her for inclusion and exclusion criteria.
Pre-assignment details
If eligible for study participation, the member of the research team will review study procedures and the risks and benefits of participation with the patient, and obtain informed consent for study participation. Once informed consent is obtained, participants will be assigned a screening number. Research staff will then administer a verbal 10-minute survey (Form 1) to collect demographic information and assess baseline pain, bleeding, nausea and other pregnancy-related symptoms.
Participants by arm
| Arm | Count |
|---|---|
| Laminaria Patients in this arm will receive laminaria cervical dilators one day before D&E procedure.
Laminaria | 89 |
| Dilapan-S Patients in this arm will receive Dilapan-S cervical dilators one day before D&E procedure.
Dilapan-S | 89 |
| Total | 178 |
Baseline characteristics
| Characteristic | Dilapan-S | Total | Laminaria |
|---|---|---|---|
| Age, Continuous | 23.80 years STANDARD_DEVIATION 4.61 | 23.90 years STANDARD_DEVIATION 4.55 | 23.99 years STANDARD_DEVIATION 4.49 |
| Race/Ethnicity, Customized African-American or Black | 45 Participants | 87 Participants | 42 Participants |
| Race/Ethnicity, Customized Hispanic or Latina | 18 Participants | 39 Participants | 21 Participants |
| Race/Ethnicity, Customized Other | 10 Participants | 28 Participants | 18 Participants |
| Race/Ethnicity, Customized White | 16 Participants | 24 Participants | 8 Participants |
| Sex: Female, Male Female | 89 Participants | 178 Participants | 89 Participants |
| Sex: Female, Male 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 / 89 | 0 / 89 |
| serious Total, serious adverse events | 0 / 89 | 0 / 89 |
Outcome results
Primary
D&E Procedure Time
Length of D&E procedure in minutes
Time frame: The primary outcome measure will be assessed on the day of the patient's D&E procedure. (day 2)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laminaria | D&E Procedure Time | 7.35 minutes | Standard Deviation 3.63 |
| Dilapan-S | D&E Procedure Time | 7.55 minutes | Standard Deviation 4.59 |