Preterm Delivery Within 7 Day After Admission Clinical Trial
Official title:
A Comparison of the Effectiveness in Management of Threatened Preterm Labor Between Cervical Length-based Approach and Conventional Approach: A Randomized Control Trial
| Verified date | August 2021 |
| Source | ChaingMai University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To compare the effectiveness of treatment of threatened preterm labor between transvaginal cervical length-based approach and conventional approach (Per vaginal examination)
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | January 2021 |
| Est. primary completion date | May 4, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Pregnant with symptoms of threatened preterm labor which refer to regular uterine contractions at least 1 time in every 10 minutes and persist for 30 minute without cervical dilatation or cervical dilation = 1 cm and < 80% of effacement. - Age = 18 years - Singleton pregnancy - 24 0/7 - 33 6/7 weeks of gestation - Uneventful antenatal care or low-risk pregnancies Exclusion Criteria: - The definitive diagnosis of true labor - Proceed to the active phase of labor - Age < 18 years - Multiple pregnancies - < 24 or = 34 weeks of gestation - Fetal chromosomal or structural abnormalities - Abnormal fetal growth - Abnormal amniotic fluid - Evidence of placenta previa - Significant vaginal bleeding that cannot be ruled out placenta previa - Evidence of rupture of membranes - Evidence of intrauterine infection - Evidence of uterine malformation - Evidence of lethal fetal malformation - Unable to communicate or understand the information of the study |
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Kuntharee Traisrisilp | Chiang Mai | |
| Thailand | Maharaj Nakorn ChiangMai Hospital | ChiangMai |
| Lead Sponsor | Collaborator |
|---|---|
| ChaingMai University |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of cases with delivery within 7 day after admission | In case of threatened preterm labor if detection the progression of labor by transvaginal cervical length, the rate of delivery within 7 days will less or more than conventional group. | From admission to no uterine contraction in 10 minute | |
| Secondary | The number of tocolysis courses, length of hospital stay | In case of tocolytic used for stop labor. The number of medication will be recorded. | From admission to no uterine contraction in 10 minute | |
| Secondary | The number of steroid courses | In case of stop labor, the course of steroid for promote lung maturity is recorded. | From admission to no uterine contraction in 10 minute |