Medical Induction of Labor Affecting FetusPhase 4NCT02508402
Effect Of Intra-muscular Administration of Dexamethasone in Induction of Labour
A Phase 4 study testing Dexamethasone in people with Medical Induction of Labor Affecting Fetus, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
ABSTRACT: Objective: To evaluate the efficacy of dexamethasone on labor duration and to establish whether dexamethasone plays a role in shorting the duration interval between initiation of labor induction and beginning of the active phase in primigravida full-term pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Medical Induction of Labor Affecting Fetus
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2015to Jul 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singleton pregnancy.
- Primigravida.
- Post-term gestation i.e. 41 weeks or more.
- Sure, reliable dates.
- Favorable cervix with Bishop score of 7 or greater.
- Longitudinal lie.
- Cephalic presentation (Vertex).
Who cannot join
- Abnormal presentation.
- Multigravida.
- Multiple pregnancies.
- Active phase of labour.
- Cephalo-pelvic disproportion.
- History of any medical disorder.
Show all 12Show fewer
- History of previous myomectomy operation.
- Known contraindication or hypersensitivity to Dexamethasone.
- Current fetal distress.
- Current maternal or fetal disorder e.g. Diabetes mellitus; Pregnancy induced hypertension, and fetal growth retardation.
- Over distended abdomen e.g. fetal macrosomia or polyhydramnios suggested by ultrasound or estimated fetal weight by expert hand.
- Significant vaginal bleeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Intra-muscular Administration of Dexamethasone on the Duration of Induction of Labour in Primigravida Post-term Pregnancy.
ABSTRACT:
Objective: To evaluate the efficacy of dexamethasone on labor duration and to establish whether dexamethasone plays a role in shorting the duration interval between initiation of labor induction and beginning of the active phase in primigravida full-term pregnancy.
Methods: case control study included 86 primigravidae with full term pregnancy classified into two groups: The participant of Group I will receive a prefilled syringe with two milliliters (8 mg) of Dexamethasone intramuscular, and the participants of Group II will not receive Dexamethasone or any other cervical ripening agent.
Key Words: Dexamethasone;post-term pregnancy;induction of labor.
Read the detailed description
METHODS:
This retrospective clinical trial was conducted at the Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, during the period from August 2014 to May 2015. The study protocol was approved by the Scientific Research Committee, and informed consent was obtained from all participants.
Each participant will randomly be assigned by computer list into Group I (Dexamethasone group(n=43)and group II(control group(N=43).
No cervical ripening agent will be used for induction of labour in the trial.
Methodology in details:
- The participant of Dexamethasone Group will receive a prefilled syringe with two milliliters (8 mg) of Dexamethasone intramuscular, and the participants of placebo Group will not receive Dexamethasone or any other cervical ripening agent.
All the participants in both groups will randomly be assigned by computer list. (Haijavandi et., al 2013)
II. After six hours of the initial dose, the labour induction will start via Oxytocin using the following protocol:
- Initial dose of oxytocin.................................. 1 to 2 milliliter international unit/min.
- Increase interval......................................................30 minutes.
- Dosage increment....................................................1 to 2 milliliter international unit/min.
- Usual dose for good labour.........................8 to12 milliliter international unit/min.
- Maximum dose…………………...................30 milliliter international unit/min. (Anne Biringer et., al 2013).
III. The interval between the initiation of induction and the beginning of the active phase of labour is recorded (a cervical dilatation of 4 cm plus 3 forceful contractions over a 10-minute span each last from 40-60 Sec).
IV. Partographic representation for progression of active phase labour:
- Frequency and duration of uterine contraction.
- Cervical dilatation will record every two hours by per vaginal examination.
- Station and position of fetal head was noted at the same time.
- After delivery:-
- The duration of the first stage of labor will be recorded. (Partographic representation will do for each participant).
- The duration of the second stage of labor will be recorded.
- The duration of the placental separation will be recorded.
- The neonatal outcome will be recorded by APGAR score.
- Any postpartum maternal adverse effect was noted (e.g. vital sign abnormality, any maternal postpartum hemorrhage).
Primary outcome:
the duration between induction and beginning of active phase.
Secondary outcome:
-Duration of first stage.
- Being tested
- Dexamethasone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called epidrone
The participant of Dexamethasone Group will receive a prefilled syringe with two milliliters (8 mg) of Dexamethasone intramuscular, and the participants of Group II will not receive Dexamethasone or any other cervical ripening agent.
All the participants in both groups will randomly be assigned by computer list.
II. After six hours of the initial dose, the labour induction will start via Oxytocin using
PlaceboDrug
Also called Normal saline
two milliliters of normal saline given to placebo group .
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone group | Active comparator | The participant of Dexamethasone Group will receive a prefilled syringe with two milliliters (8 mg) of Dexamethasone intramuscular After six hours of the initial dose, the labour induction will start via Oxytocin .III. The interval between the initiation of induction and the beginning of the active phase of labour is recorded (a cervical dilatation of 4 cm plus 3 forceful contractions over a 10-minute span each last from 40-60 Sec). Receives: Drug: Dexamethasone |
| Placebo group | Placebo comparator | and the participants of placebo Group will not receive Dexamethasone or any other cervical ripening agent.II.two milliliters of normal saline given. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the duration between induction and beginning of active phase.
Measured: 6 months
Secondary outcomes (1)
Duration of first stage.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Induction of Labor Affecting FetusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed El-Sharkawy, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508402
- Sponsor's protocol ID
- KasrELAiniH
- Status last verified
- Sep 2015
- First submitted
- 14 Jul 2015
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Intra-muscular Administration of Dexamethasone on the Duration of Induction of Labour in Primigravida Post-term Pregnancy.
- ClinicalTrials.gov ID
- NCT02508402
- Acronym / sponsor ID
- KasrELAiniH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 24 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ABSTRACT:
Objective: To evaluate the efficacy of dexamethasone on labor duration and to establish whether dexamethasone plays a role in shorting the duration interval between initiation of labor induction and beginning of the active phase in primigravida full-term pregnancy.
Methods: case control study included 86 primigravidae with full term pregnancy classified into two groups: The participant of Group I will receive a prefilled syringe with two milliliters (8 mg) of Dexamethasone intramuscular, and the participants of Group II will not receive Dexamethasone or any other cervical ripening agent.
Key Words: Dexamethasone;post-term pregnancy;induction of labor.
Detailed description
METHODS:
This retrospective clinical trial was conducted at the Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, during the period from August 2014 to May 2015. The study protocol was approved by the Scientific Research Committee, and informed consent was obtained from all participants.
Each participant will randomly be assigned by computer list into Group I (Dexamethasone group(n=43)and group II(control group(N=43).
No cervical ripening agent will be used for induction of labour in the trial.
Methodology in details:
- The participant of Dexamethasone Group will receive a prefilled syringe with two milliliters (8 mg) of Dexamethasone intramuscular, and the participants of placebo Group will not receive Dexamethasone or any other cervical ripening agent.
All the participants in both groups will randomly be assigned by computer list. (Haijavandi et., al 2013)
II. After six hours of the initial dose, the labour induction will start via Oxytocin using the following protocol:
- Initial dose of oxytocin.................................. 1 to 2 milliliter international unit/min.
- Increase interval......................................................30 minutes.
- Dosage increment....................................................1 to 2 milliliter international unit/min.
- Usual dose for good labour.........................8 to12 milliliter international unit/min.
- Maximum dose…………………...................30 milliliter international unit/min. (Anne Biringer et., al 2013).
III. The interval between the initiation of induction and the beginning of the active phase of labour is recorded (a cervical dilatation of 4 cm plus 3 forceful contractions over a 10-minute span each last from 40-60 Sec).
IV. Partographic representation for progression of active phase labour:
- Frequency and duration of uterine contraction.
- Cervical dilatation will record every two hours by per vaginal examination.
- Station and position of fetal head was noted at the same time.
- After delivery:-
- The duration of the first stage of labor will be recorded. (Partographic representation will do for each participant).
- The duration of the second stage of labor will be recorded.
- The duration of the placental separation will be recorded.
- The neonatal outcome will be recorded by APGAR score.
- Any postpartum maternal adverse effect was noted (e.g. vital sign abnormality, any maternal postpartum hemorrhage).
Primary outcome:
the duration between induction and beginning of active phase.
Secondary outcome:
-Duration of first stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexamethasone group | Active comparator | Drug: DexamethasoneThe participant of Dexamethasone Group will receive a prefilled syringe with two milliliters (8 mg) of Dexamethasone intramuscular After six hours of the initial dose, the labour induction will start via Oxytocin .III. The interval between the initiation of induction and the beginning of the active phase of labour is recorded (a cervical dilatation of 4 cm plus 3 forceful contractions over a 10-minute span each last from 40-60 Sec). |
| Placebo group | Placebo comparator | Drug: Placeboand the participants of placebo Group will not receive Dexamethasone or any other cervical ripening agent.II.two milliliters of normal saline given. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Singleton pregnancy.
- Primigravida.
- Post-term gestation i.e. 41 weeks or more.
- Sure, reliable dates.
- Favorable cervix with Bishop score of 7 or greater.
Key exclusion criteria (12 listed)
- Abnormal presentation.
- Multigravida.
- Multiple pregnancies.
- Active phase of labour.
- Cephalo-pelvic disproportion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: epidroneThe participant of Dexamethasone Group will receive a prefilled syringe with two milliliters (8 mg) of Dexamethasone intramuscular, and the participants of Group II will not receive Dexamethasone or any other cervical ripening agent. All the participants in both groups will randomly be assigned by computer list. II. After six hours of the initial dose, the labour induction will start via Oxytocin using | Drug | dexamethasone group |
| PlaceboAlso: Normal salinetwo milliliters of normal saline given to placebo group . | Drug | Placebo group |
Primary outcome
the duration between induction and beginning of active phase.
Time frame: 6 months
1 secondary outcome
Duration of first stage.
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone in people with Medical Induction of Labor Affecting Fetus, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the duration between induction and beginning of active phase. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2016.