Disorder of Amniotic Cavity and/or Membrane
Conditions
Keywords
cervical length, sweeping the membranes
Brief summary
Sweeping the membranes in term pregnancy may shorten the cervix and reduce the time to delivery.
Detailed description
Cervical length will be measured in both groups. The membranes will be swept in pregnancies beyond 38 weeks by digital examination in the study group. The control group will only be examined for Bishop score. Two days later cervical length will be Measured once more.
Interventions
PROCEDUREsweeping the membranes
The cervical length will be measured and the patient will be examined to determine the Bishop score. Later the the membranes will be swept.
OTHERNo sweeping group
Cervical length will be measured by transvaginal USG and the patient will be examined to determine the Bishop score.
Sponsors
Baskent University
Huriye Ayse Parlakgumus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
Yes
Inclusion criteria
* The patients who completed the 38th week of pregnancy, otherwise healthy gravida who have no contraindication to vaginal delivery.
Exclusion criteria
* Women who have chronic disease complicating pregnancy, multiple pregnancies and in whom vaginal delivery is contraindicated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cervical Shortening | 2days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Duration of Latency Until Labor | 15 days | The period (in days) from the last cervical measurement to the start of second phase of labor. |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
february-March 2011- department of obstetrics and gynecology
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| The Membranes Swept Group The patient whose amniotic membranes are detached by the circular movements of the examining fingers | 75 |
| No Sweeping Group The patients who did not have sweeping of the membranes | 75 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 4 |
Baseline characteristics
| Characteristic | No Sweeping Group | The Membranes Swept Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 75 Participants | 75 Participants | 150 Participants |
| Age Continuous | 28.11 years STANDARD_DEVIATION 4.78 | 27.25 years STANDARD_DEVIATION 5.06 | 27.69 years STANDARD_DEVIATION 4.92 |
| Region of Enrollment Turkey | 75 participants | 75 participants | 150 participants |
| Sex: Female, Male Female | 75 Participants | 75 Participants | 150 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 / 75 | 0 / 75 |
| serious Total, serious adverse events | 0 / 75 | 0 / 75 |
Outcome results
Primary
Cervical Shortening
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.
Time frame: 2days
Population: analysis was per person who delivered
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sweeping | Cervical Shortening | cervix1 | 27.45 millimeters | Standard Deviation 8.39 |
| Sweeping | Cervical Shortening | cervix2 | 23.30 millimeters | Standard Deviation 8.84 |
| Sweeping | Cervical Shortening | cervical shortening | 5.15 millimeters | Standard Deviation 4.42 |
| Not Swept | Cervical Shortening | cervix1 | 29.61 millimeters | Standard Deviation 8.97 |
| Not Swept | Cervical Shortening | cervix2 | 23.88 millimeters | Standard Deviation 8.52 |
| Not Swept | Cervical Shortening | cervical shortening | 5.72 millimeters | Standard Deviation 4.37 |
Secondary
The Duration of Latency Until Labor
The period (in days) from the last cervical measurement to the start of second phase of labor.
Time frame: 15 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sweeping | The Duration of Latency Until Labor | 6.33 days | Standard Deviation 4.57 |
| Not Swept | The Duration of Latency Until Labor | 5.69 days | Standard Deviation 4.11 |