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A study to find the better method to assess the neck of the womb before artificially starting the process of child birth by inserting a drug called “Dinoprostone” (prostaglandin) through the birth passage

A randomized controlled trial to compare, sonographically measured cervical length with modified Bishop Score in determining the requirement for prostaglandin administration for preinduction cervical ripening in nulliparae at term

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2014/027
Enrollment
Unknown
Registered
2014-10-13
Start date
2014-11-02
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical length and favourability of cervix for induction of labour

Interventions

Consenting participants will be randomized into two arms. In the first arm the suitability of the cervix to insert prostaglandin will be determined using the trans-vaginal scan. In the second arm,

Sponsors

De Soysa Hospital for Women, Colombo 08.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Nulliparous women 2. Singleton pregnancy 3. Live foetus with vertex presentation 4. Intact amniotic membranes 5. POA>40 weeks gestation who admitted for induction of labour 6. Absence of previous uterine procedures 7. Gestational age confirmed by ultrasound scan between 11-20 weeks

Exclusion criteria

Exclusion criteria: 1. Previous cone biopsy 2. History of caesarean section or major uterine surgery 3. Patients with active cardiac or pulmonary disease 4. Placenta praevia 5. Unexplained vaginal bleeding during pregnancy 6. Major cephalopelvic disproportions 7. Foetal malpresentations

Design outcomes

Primary

MeasureTime frame
Successful induction of labour -defined as, an ability to achieve the active phase of labour corresponding to a cervical dilatation of >4 cm after one cycle of the administration of a dinoprostone vaginal pessary on the first day of induction with regular uterine contractions.(three or more moderate contractions per 10 min.) [14 hours after first prostaglandin insertion]

Secondary

MeasureTime frame
1. Interval from start of induction by amniotomy to any type of delivery 2. Interval from time of insertion of prostaglandins to vaginal delivery 3. Need for oxytocin augmentation after amniotomy 4. Interval from time of insertion of prostaglandins to beginning of active phase 5. Number of women with spontaneous rupture of membranes and interval from time of insertion of prostaglandins to this event 6. Route of delivery 7. Number of women with cesarean section for failed induction 8. Meconium passage 9. Birth weight 10. Apgar scores 11. Number of infants admitted to neonatal intensive care unit. 12. Percentage of failed inductions, defined as labour failing to start after one cycle of treatment with medical methods or 12 hours of amniotomy. [From the time of induction to 24 hours after delivery]

Countries

Sri Lanka

Contacts

Public ContactDr.M.Kumarasiri

Registrar in Obstetrics & Gynaecology

kumarasirim@yahoo.com0112662619

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026