N/A
Completed N=60
Are Uterine Natural Killer Cells Involved in the Initiation of Preterm Labor ?
Preterm Labour
Source: ClinicalTrials.gov NCT02284867 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Uterine Natural Killer Cells In Preterm Labor — 21; 1; 0; 0 participants — p=<0.0002
Summary
Research question:
Population of study: women diagnosed as term pregnancy in labor (control) and the other group diagnosed as preterm labor (cases).
Intervention: measuring uterine natural killer cells . Outcome: uterine natural killer cells has a role in initiation of preterm labor.
Research hypothesis:
• Are uterine Natural Killer cells involved in the initiation of preterm labor ?
Medical Application:
• Possibility of prediction of preterm labor by assessment of Natural killer cells as well as preventing preterm labor by suppressing their activity .
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Uterine Natural Killer Cells In Preterm Labor |
21; 1; 0; 0 | <0.0002 sig |
| SECONDARY Comparison of CD16+ CD56 Dim Uterine Natural Killer Cells (uNK) Prevalence in Decidua vs. Villi in Placenta of Both Study Groups |
1; 10; 0; 11 | — |
Eligibility Criteria
Inclusion Criteria
- Maternal age: 18-35 years old (to decrease the incidence of preterm labor related to age factor).
- Women who present with viable pregnancy (between 28 and 37 weeks' gestation), and having a threatened preterm labor (which is defined as ≥ 2 uterine contractions at 28-37 weeks' gestation, The onset of labor may be determined by documented uterine contractions (at least one every 10 minutes) and ruptured fetal membranes or documented cervical change with an estimated length of less than 1cm or cervical dilation of more than 2 cm. Threatened preterm labor may be diagnosed when there are documented uterine contractions but no evidence of cervical change.
Exclusion Criteria
- Multiple pregnancy.
- Documented uterine anomalies.
- Oligohydramnios and polyhydramnios .
- Medical disorders as Diabetes mellitus and hypertension.
- Preterm premature rupture of membranes.
- Conditions that may have an influence on immune reaction e.g. history of chorioamnionitis.
- Smoking as a risk factor for preterm labor.
- Patients having Autoimmune disorder as it may affect Uterine NK( natural killer ) cells level .
Data sourced from ClinicalTrials.gov (NCT02284867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.