Trial Outcomes & Findings for Sweeping the Membranes, Cervical Length and Duration of Labor (NCT NCT01309308)

Results Overview

Cervix 1 was measured at the sagittal plane of cervix from external to the internal os. Two days later cervix 2 was measured the same way. The cervical shortening was calculated from subtracting cervix 1 from cervix 2.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

150 participants

Primary outcome timeframe

2days

Results posted on

2011-10-07

Participant Flow

february-March 2011- department of obstetrics and gynecology

The participants are excluded from the study after assignment to the groups if they did not attend the second ultrasound measurement or if they delivered in another clinic.

Participant milestones

Participant milestones
Measure	The Membranes Swept Group The patient whose amniotic membranes are detached by the circular movements of the examining fingers	No Sweeping Group The patients who did not have sweeping of the membranes
Overall Study STARTED	75	75
Overall Study COMPLETED	69	71
Overall Study NOT COMPLETED	6	4

Reasons for withdrawal

Reasons for withdrawal
Measure	The Membranes Swept Group The patient whose amniotic membranes are detached by the circular movements of the examining fingers	No Sweeping Group The patients who did not have sweeping of the membranes
Overall Study Lost to Follow-up	6	4

Baseline Characteristics

Sweeping the Membranes, Cervical Length and Duration of Labor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	The Membranes Swept Group n=75 Participants The patient whose amniotic membranes are detached by the circular movements of the examining fingers	No Sweeping Group n=75 Participants The patients who did not have sweeping of the membranes	Total n=150 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	75 Participants n=5 Participants	75 Participants n=7 Participants	150 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	27.25 years STANDARD_DEVIATION 5.06 • n=5 Participants	28.11 years STANDARD_DEVIATION 4.78 • n=7 Participants	27.69 years STANDARD_DEVIATION 4.92 • n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	75 Participants n=7 Participants	150 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 Turkey	75 participants n=5 Participants	75 participants n=7 Participants	150 participants n=5 Participants

PRIMARY outcome

Timeframe: 2days

Population: analysis was per person who delivered

Cervix 1 was measured at the sagittal plane of cervix from external to the internal os. Two days later cervix 2 was measured the same way. The cervical shortening was calculated from subtracting cervix 1 from cervix 2.

Outcome measures

Outcome measures
Measure	Sweeping n=69 Participants In women who had completed 38 weeks of gestation sweeping was performed by separating the lower membranes as much as possible from their cervical attachment, with three circumferential passes of the examining fingers for only once.	Not Swept n=71 Participants Patients whose membranes are not swept
Cervical Shortening cervix1	27.45 millimeters Standard Deviation 8.39	29.61 millimeters Standard Deviation 8.97
Cervical Shortening cervix2	23.30 millimeters Standard Deviation 8.84	23.88 millimeters Standard Deviation 8.52
Cervical Shortening cervical shortening	5.15 millimeters Standard Deviation 4.42	5.72 millimeters Standard Deviation 4.37

SECONDARY outcome

Timeframe: 15 days

The period (in days) from the last cervical measurement to the start of second phase of labor.

Outcome measures

Outcome measures
Measure	Sweeping n=69 Participants In women who had completed 38 weeks of gestation sweeping was performed by separating the lower membranes as much as possible from their cervical attachment, with three circumferential passes of the examining fingers for only once.	Not Swept n=71 Participants Patients whose membranes are not swept
The Duration of Latency Until Labor	6.33 days Standard Deviation 4.57	5.69 days Standard Deviation 4.11

Adverse Events

The Membranes Swept Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Sweeping Group

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

Ayse Parlakgumus

Baskent University

Phone: 00903224586868

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place