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Original TRDS for trail "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" created on Oct 22, 2014


SLCTR Registration Number

SLCTR/2014/027

Date of Registration

13 Oct 2014

The date of last modification

Oct 22, 2014

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Application Summary

Scientific Title of Trial

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

Public Title of Trial

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

Disease or Health Condition(s) Studied

cervical length and favourability of cervix for induction of labour

Scientific Acronym

None

Public Acronym

None

Brief title

None

Universal Trial Number

U1111-1156-5256

Any other number(s) assigned to the trial and issuing authority

EC-14-001, Ethics Review Committee, Faculty of Medicine, University of Colombo


Trial Details

What is the research question being addressed?

Is sonographically measured cervical length more accurate than the Modified Bishop Score in determining the requirement for prostaglandin administration for pre-induction cervical ripening in nulliparae at term?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Double blinded

Control

Active

Assignment

Parallel

Purpose

Supportive care

Study Phase

Intervention(s) planned

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, the suitability of the cervix to insert prostaglandin will be determined using the Modified Bishop Score.

Only patients who will need prostaglandin will be included in the study. If the status of the cervix is unfavorable, a 3-mg dinoprostone vaginal pessary will be placed transversely in the posterior fornix of the vagina at 3: 00 p.m. to initiate cervical ripening before labor induction. After 6 h, i.e. at 9: 00 p.m. another pessary will be inserted if required. Amniotomy will not be performed until the cervix dilates to at least 3 cm and till the head engages.

Both groups will be assessed using both methods to avoid bias

The assessment will be done by the Senior House Officer in the ward who will know the two groups of patients.

All other standard therapy will be offered equally to both groups.

The Primary outcome which will be successful induction of labour will be assessed by the PI

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

  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

Primary outcome(s)

1.

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 outcome(s)

1.
  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

]

Target number/sample size

160 (80 in each arm)

Countries of recruitment

Sri Lanka

Anticipated start date

2014-11-02

Anticipated end date

2016-11-02

Date of first enrollment

Date of study completion

Recruitment status

Pending

Funding source

None

Regulatory approvals


State of Ethics Review Approval

Status

Date of Approval

Approval number

Details of Ethics Review Committee

Name:
Institutional Address:
Telephone:
Email:

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Dr.M.Kumarasiri
Registrar in Obstetrics & Gynaecology
De Soysa Hospital for Women, Colombo 08.
0112662619
0714210119

kumarasirim@yahoo.com

Contact Person for Public Queries

Dr.U.D.P.Ratnasiri
Consultant Obstetrician & Gynaecologist,
De Soysa Hospital for Women, Colombo 08.
0112662619
0718070550

udpratnasiri@yahoo.com

Primary study sponsor/organization

De Soysa Hospital for Women, Colombo 08.

Sri Lanka
Tel-0112662619
Fax-0112697315
dmhteaching@gmail.com
http://www.dmh.health.gov.lk/

Secondary study sponsor (If any)

None





Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results