Trial Outcomes & Findings for Dilapan Versus Laminaria (NCT NCT00775983)

Results Overview

Procedure time to complete early second-trimester dilation and evacuation (D\&E)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

72 participants

Primary outcome timeframe

Day of procedure

Results posted on

2013-11-14

Participant Flow

Women were recruited for the study at the Women's Options Center at San Francisco General Hospital (SFGH) between October 2008 and February 2010. SFGH is San Francisco's county hospital and serves a diverse and mostly uninsured population.

Of 72 eligible and enrolled participants, 3 did not receive an abortion (2 in the Same-day Dilapan-S group, and 1 in the Overnight laminaria group).

Participant milestones

Participant milestones
Measure	Laminaria laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.	Dilapan-S For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
Overall Study STARTED	36	36
Overall Study COMPLETED	35	34
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Laminaria laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.	Dilapan-S For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
Overall Study Protocol Violation	1	2

Baseline Characteristics

Dilapan Versus Laminaria

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Laminaria n=35 Participants laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.	Dilapan-S n=34 Participants For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.	Total n=69 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants	32 Participants n=7 Participants	66 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	24 years STANDARD_DEVIATION 7 • n=5 Participants	27 years STANDARD_DEVIATION 6 • n=7 Participants	26 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	34 Participants n=7 Participants	69 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants	34 participants n=7 Participants	69 participants n=5 Participants

PRIMARY outcome

Timeframe: Day of procedure

Population: All patients who received a surgical abortion procedure were analyzed. Since three patients did not actually obtain an abortion within the study timeframe, we could not analyze their data, thus the analysis was per protocol.

Procedure time to complete early second-trimester dilation and evacuation (D\&E)

Outcome measures

Outcome measures
Measure	Overnight Laminaria n=35 Participants Overnight laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.	Dilapan-S n=34 Participants For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
Procedure Time	5.9 minutes Standard Error 2.9	8.1 minutes Standard Error 5.5

SECONDARY outcome

Timeframe: Day of procedure

Population: All patients who received a surgical abortion procedure were analyzed. Since three patients did not actually obtain an abortion within the study timeframe, we could not analyze their data, thus the analysis was per protocol.

Any complications, or mechanical dilation required, for early second-trimester surgical abortions performed after cervical preparation with same-day Dilapan versus those performed after cervical preparation with overnight laminaria

Outcome measures

Outcome measures
Measure	Overnight Laminaria n=35 Participants Overnight laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.	Dilapan-S n=34 Participants For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
Participants Who Experienced Complications or Need for Additional Dilation Bleeding requiring uterotonics	10 participants	7 participants
Participants Who Experienced Complications or Need for Additional Dilation Reaspiration	2 participants	3 participants
Participants Who Experienced Complications or Need for Additional Dilation Cervical laceration	1 participants	0 participants
Participants Who Experienced Complications or Need for Additional Dilation Additional dilation	8 participants	22 participants

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

Abby Sokoloff

UCSF

Phone: 4155140440

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place