Induction of Labor Clinical Trial
— PRODUCTOfficial title:
What After the First Propess. A Randomised Comparative Prospective Study
NCT number | NCT02956785 |
Other study ID # | 202984 |
Secondary ID | |
Status | Terminated |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | November 2022 |
Verified date | November 2022 |
Source | South Warwickshire NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to compare three different regimens for continuation of induction of labor after no spontaneous or artificial rupture of membranes could be achieved after first 24 hours post-insertion of Dinoprostone
Status | Terminated |
Enrollment | 85 |
Est. completion date | November 2022 |
Est. primary completion date | November 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Women booked for induction of labor at 37 to 42 weeks gestation - Viable singleton pregnancy. - Cephalic presentation. - Intact membranes. - No previous Caesarean section. - No antenatal fetal concerns (Fetal growth restriction (FGR), small for gestational age (SGA), impaired Doppler, oligohydramnios, non-reassuring/abnormal CTG). Exclusion Criteria: - Pregnancy less than completed 37 weeks or more than 42 weeks. - Multiple pregnancy. - Intrauterine fetal death. - Non-cephalic presentation. - Pre-labor rupture of membranes - Previous one or more Caesarean sections. - Antenatal concerns regarding fetal well-being (FGR, SGA, impaired Doppler, oligohydramnios, non-reassuring/abnormal CTG). - Non-reassuring or abnormal CTG on admission to labor ward |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Walsall Healthcare NHS Trust | Walsall |
Lead Sponsor | Collaborator |
---|---|
South Warwickshire NHS Foundation Trust | Medicem International, Walsall Healthcare NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of achieving spontaneous or artificial rupture of membranes | percentage of women who will have spontaneous or artificial rupture of membranes | 12 months | |
Secondary | Time interval needed from start of induction of labor to achieve spontaneous or artificial rupture of membranes | The time frame is 6 months from the onset of the study till assessing the results, doing the analysis and presenting. But, the time interval stated as an outcome here is the period of time elapsing from starting induction of labour and rupturing the membranes whether spontaneous or artificial |
12 months | |
Secondary | Rate of hyperstimulation (contractions more than 5 in 10 minutes or each contraction lasting more than 90 seconds) | percentage of women who will develop uterine hyperstimulation | 12 months | |
Secondary | Rate of abnormal CTG changes needing intervention | percentage of women with non-reassuring or abnormal CTG that need intervention | 12 months | |
Secondary | Rate of need for tocolysis | percentage of women who need tocolysis to treat hyperstimulation | 12 months | |
Secondary | Rate of emergency Caesarean section | percentage of women who need Caesarean section for fetal distress or failed induction/progress of labour | 12 months | |
Secondary | Grades of Caesarean sections | percentage of each of grade 1,2 and 3 Caesarean sections among each group | 12 months | |
Secondary | Women's satisfaction with the method of induction used | scoring system based on women's questionnaire formed of 3 questions with a score of 3 to 15. In addition, evaluation of pain score out of 10 | 12 months |
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