Trial Outcomes & Findings for Laminaria Compared to Dilapan-S for Cervical Preparation Before Dilation and Evacuation at 18-24 Weeks of Gestation (NCT NCT02033083)

NCT ID: NCT02033083

Last Updated: 2021-07-12

Results Overview

Length of D\&E procedure in minutes

Recruitment status

COMPLETED

Study phase

Target enrollment

180 participants

Primary outcome timeframe

The primary outcome measure will be assessed on the day of the patient's D&E procedure. (day 2)

Results posted on

2021-07-12

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Laminaria Patients in this arm will receive laminaria cervical dilators one day before D\&E procedure. Laminaria	Dilapan-S Patients in this arm will receive Dilapan-S cervical dilators one day before D\&E procedure. Dilapan-S
Overall Study STARTED	90	90
Overall Study COMPLETED	89	89
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Laminaria Compared to Dilapan-S for Cervical Preparation Before Dilation and Evacuation at 18-24 Weeks of Gestation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Laminaria n=89 Participants Patients in this arm will receive laminaria cervical dilators one day before D\&E procedure. Laminaria	Dilapan-S n=89 Participants Patients in this arm will receive Dilapan-S cervical dilators one day before D\&E procedure. Dilapan-S	Total n=178 Participants Total of all reporting groups
Age, Continuous	23.99 years STANDARD_DEVIATION 4.49 • n=5 Participants	23.80 years STANDARD_DEVIATION 4.61 • n=7 Participants	23.90 years STANDARD_DEVIATION 4.55 • n=5 Participants
Sex: Female, Male Female	89 Participants n=5 Participants	89 Participants n=7 Participants	178 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized African-American or Black	42 Participants n=5 Participants	45 Participants n=7 Participants	87 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latina	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
Race/Ethnicity, Customized White	8 Participants n=5 Participants	16 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized Other	18 Participants n=5 Participants	10 Participants n=7 Participants	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Laminaria n=88 Participants Patients in this arm will receive laminaria cervical dilators one day before D\&E procedure. Laminaria	Dilapan-S n=88 Participants Patients in this arm will receive Dilapan-S cervical dilators one day before D\&E procedure. Dilapan-S
D&E Procedure Time	7.35 minutes Standard Deviation 3.63	7.55 minutes Standard Deviation 4.59

Adverse Events

Laminaria

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dilapan-S

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

Director of Clinical Training and Research

Planned Parenthood of New York City

Phone: 212-274-7340

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place