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Effect of Dexamethasone on Labour Induction in Term Pregnancies

ConditionLabor Induction
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCairo University

About this trial

The aim of the study is to assess the effect of dexamethasone on labour induction in term pregnancies.

Primary outcome:

The interval between initiation of induction and beginning of the active phase of labour.

Secondary outcomes:

* Duration of active phase of labour (starting with cervical dilatation of 4-5 cm up to full cervical dilatation). * Duration of second stage of labour * Mode of delivery. * Fetal outcome.

Group A:

Will receive one dose of IM dexamethasone sodium phosphate 8 mg (2 mL).

Group B:

Will receive vaginal misoprostol 25 μg tablets every 6 h, up to 4 tablets, for a maximum duration of 24 h.

Group C:

Will receive one dose of IM dexamethasone sodium phosphate 8mg (2mL) with the first dose of vaginal misoprostol 25 μg tablets that will be given every 6 h, up to 4 tablets, for a maximum duration of 24 h.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age > 18 years.

Nulliparous.

Vertex presentation.

Singleton pregnancy.

Disqualifiers

Indication for cesarean section e. g. Placenta previa, intrauterine growth retardation, non-vertex presentation and previous cesarean section.

Maternal medical disorders as diabetes mellitus and severe pre-eclampsia.

Preterm labour and preterm rupture of membranes.

Gestational age <39 weeks of gestation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexamethasone (Decadron) 8mg IM injection

    Drug

    one dose of IM dexamethasone sodium phosphate 8 mg (2 mL) given at the start of labour induction

  • Misoprostol 25 mcg

    Drug

    vaginal misoprostol 25 μg tablets every 6 h, up to 4 tablets, for a maximum duration of 24 h.

  • Both Misoprostol 25 mcg & Dexamethasone 8mg IM injection

    Drug

    one dose of IM dexamethasone sodium phosphate 8mg (2mL) with the first dose of vaginal misoprostol 25 μg tablets that will be given every 6 h, up to 4 tablets, for a maximum duration of 24 h.

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BActive comparator 1 intervention
Group C: Group CExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The interval between initiation of induction and beginning of the active phase of labour.

Assessed hourly

Time frame
The interval between initiation of induction and beginning of the active phase of labour, assessed hourly up to 24 hours.

Secondary outcomes

1

Duration of active phase of labour (starting with cervical dilatation of 4-5 cm up to full cervical dilatation).

Assessed hourly

Time frame
Duration of active phase of labour (starting with cervical dilatation of 4-5 cm up to full cervical dilatation), assessed hourly up to 24 hours.
2

Duration of second stage of labour

Time frame
Recorded immediately with delivery of the baby
3

Mode of delivery

Vaginal or Cesarean

Time frame
After induction attempt (24 hours)
4

Fetal outcome

APGAR score

Time frame
At 1 and 5 minutes after delivery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
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