None listed
Conditions
Brief summary
This study will include women with threatened preterm labor between 24-36 weeks+6 in the study group and women without preterm labor as controls (women without symptoms of preterm labor before 37 weeks` admitted for monitoring). Examination of the studied women using sterile speculum for cervico-vaginal fluid sampling and PremaQuick test before the trans-vaginal assessment of the cervical length and before digital vaginal examination. The cervico-vaginal fluid sampling followed by trans-vaginal cervical length and digital vaginal examination for cervical assessment regarding; its consistency, position, effacement and cervical dilatation. Studied women will be managed according to the results of the PremaQuick test, trans-vaginal cervical length and the clinical findings. Follow-up of the studied women will be done weekly in the obstetrics outpatients` clinic after discharge from the hospital until delivery to detect the accuracy of the PremaQuick test in detection of preterm labor.
Interventions
Pregnant women with singleton pregnancy, intact membranes, between 24-36 weeks+6, presented with regular uterine contractions lasting at least 30 seconds and occurring at least four times per 30 minutes with significant cervical changes on digital examination (cervical dilatation less than 3 cm, cervical effacement less than or equal 50%) will constitute the study group. After complete history and abdominal examination, laboratory investigation will be done according to the hospital protocols.
Pregnant women with singleton pregnancy, intact membranes, between 24-36 weeks+6, presented with regular uterine contractions lasting at least 30 seconds and occurring at least four times per 30 minutes with significant cervical changes on digital examination (cervical dilatation less than 3 cm, cervical effacement less than or equal 50%) will constitute the study group. After complete history and abdominal examination, laboratory investigation will be done according to the hospital protocols. Examination of the studied women using sterile speculum (no lubricants and/or antiseptics) for cervico-vaginal fluid sampling and PremaQuick test before the trans-vaginal assessment of the cervical length and before digital vaginal examination. The cervico-vaginal fluid sampling followed by trans-vaginal cervical length and digital vaginal examination. Studied women will be managed according to the hospital protocol depending on the results of the PremaQuick test, trans-vaginal cervical length and the clinical findings. Follow-up of the studied women will be done weekly in the obstetrics outpatients` clinic after discharge from the hospital until delivery. The main outcome measures; the accuracy of the PremaQuick test in detection of preterm labor in symptomatic women presented with threatened preterm labor. Duration of the intervention 3 minutes and the cervico-vaginal sampling will be done by the registrar on-call or by the head nurse of the obstetric ward under supervision of the registrar on-call.
Sponsors
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait.
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria includes; Pregnant women with singleton pregnancy, intact membranes, between 24-36 weeks+6, presented with regular uterine contractions lasting at least 30 seconds and occurring at least four times per 30 minutes with significant cervical changes on digital examination (cervical dilatation less than 3 cm, cervical effacement less than or equal 50%).
Exclusion criteria
Exclusion criteria includes; pregnant women equal or more than 37 weeks, twins or triplets, dilated cervix equal or more than 3 cm, rupture of fetal membranes, congenital fetal anomalies or intra uterine fetal demise or ante-partum hemorrhage.
Outcome results
None listed