Preterm Labor
Conditions
Keywords
Threatened preterm labour, vaginal progesterone, nifedipine
Brief summary
So, a number of studies have been conducted worldwide to find a suitable agent for arresting threatened preterm labor. The current study is planned to examine the effectiveness of nifedipine and progesterone in the treatment of threatened preterm labor (TPL). The result of this study will be used to recommend the best treatment modality in our population to reduce the risk of preterm labor
Detailed description
Preterm birth is defined as any birth before 37 completed weeks of gestation, or fewer than 259 days of gestation. It is estimated that annually, 13 million preterm infants are born. The worldwide rates of preterm birth vary with an estimated prevalence of 5-25%. Approximately 60% of preterm infants are born in south Asia and sub-Saharan Africa. Progesterone and nifedipine were tested as tocolytic medications in women who were at risk of preterm birth to see whether they had any influence on efficacy, success, and the effects on the mother and foetus. Nifedipine is a drug which was reported for stopping uterine contractions in preterm labour. It is calcium channel blockers have some qualities that make them a better choice as compared to others. They decrease calcium entry through cell membranes, so controlling muscle contractility in various tissues like uterus. However; its use for maintenance tocolysis has yielded conflicting results. Various interventions have been attempted to reduce the risk of preterm birth in women at increased risk, including progesterone, cervical cerclage, and cervical pessary. Progesterone plays a role in the maintenance of pregnancy by suppression of the calcium-calmodulin-myosin light chain kinase system. Additionally, progesterone has recognized anti-inflammatory properties, raising a possible link between inflammatory processes, alterations in progesterone receptor expression and the onset of preterm labor.
Interventions
DRUGVaginal progesterone 200mg daily
In Group B, participants will be instructed to use vaginal micronized progesterone tablets at a dosage of 200mg once daily or until reaching 37 weeks of gestational age or until cervical dilation exceeded 4cm (for a duration of 48 hours)
DRUGNifedipine 20 Mg
In Group A, participants will receive oral nifedipine at a dose of 20mg every 30 minutes for three doses initially, followed by long-acting nifedipine SR 20mg every 12 hours until reaching 37 weeks of gestational age or until cervical dilation exceeded 4cm (for a duration of 48 hours).
Sponsors
Dr Mudassar Saeed Pansota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* All the females aged 18-35 year * Singleton pregnancy * With gestational age of 24 weeks to 36 weeks * With presentation of the threatened preterm labor
Exclusion criteria
* Pregnant women with presentation cervical dilation (\>3 cm), * Patients with known contraindications to receiving either vaginal progesterone or oral nifedipine * Patients with co morbidities such as GDP, gestational hypertension, preeclampsia * Multiple pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of efficacy | 48 hours | Efficacy will be labeled in terms of delaying the delivery beyond 48 hours from the initiation of therapy or absence of preterm birth |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORAqdas Aziz, MBBS
Hilal-e-Ahmar Hospital, Faisalabad
Outcome results
None listed