Labor Onset and Length AbnormalitiesNCT06151925
Laminaria Tents Versus Vaginal Prostaglandin in Cervical Ripening
A study testing Laminaria and Vaginal prostaglandin in people with Labor Onset and Length Abnormalities, run by Ain Shams University at 1 site in Egypt.
Trial summary
Mechanical methods used for induction of labor received a great attention nowadays due to the serious side effects of the pharmacological methods. Hygroscopic dilators are considered important subtype of these mechanical methods. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Onset and Length Abnormalities
- What is being tested?
- Laminaria and Vaginal prostaglandin
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 30 Jun 2023
- Phase
- Interventional
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women with:
- Age 18-45 years.
- Live fetus with cephalic presentation.
- Normal non-stress test with reassuring features (baseline heart rate 110-160 beats/min, baseline variability 5-25 beats/minute, and no decelerations) (National Institute for Health and Clinical Excellence 2017).
- Gestational age of 37 weeks or more (Middleton et al. 2020).
- Fetal weight less than 4 kilograms.
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- Bishop score less than 6 (Navve et al. 2017).
- No labor pains.
- No contraindications for vaginal delivery
Who cannot join
- o Presence of fetal distress.
- Presence of thick meconium-stained amniotic fluid
- Presence of fever, chorioamnionitis, or vaginal bleeding before intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laminaria Tents Versus Vaginal Prostaglandin in Cervical Ripening in Term Induction of Labor With Unfavorable Cervix:A Randomized Controlled Trial
Mechanical methods used for induction of labor received a great attention nowadays due to the serious side effects of the pharmacological methods. Hygroscopic dilators are considered important subtype of these mechanical methods. One of them is Laminaria which is a synthetic type of sea algae that induces cervical dilation by absorbing water from the cervix and gradually increasing in thickness. The current study will compare the effectiveness and safety of laminiria and vaginal prostaglandins in induction of labor in women with unfavorable cervix.
Read the detailed description
A new method for induction of labor to be studied
- Conditions
- Labor Onset and Length Abnormalities
- Being tested
- Laminaria, Vaginal prostaglandin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaminariaDevice
mechanical method for induction of labor
Vaginal prostaglandinDrug
Also called Vagiprost
Vaginal prostaglandin for ripening
| Study group | Role | What they receive |
|---|---|---|
| Laminaria tents group | Active comparator | Laminaria tent used to be inserted in cervix and left for 6-12 hours Receives: Device: Laminaria; Drug: Vaginal prostaglandin |
| vaginal prostaglandin group | Placebo comparator | Misoprostol 25 mcg inserted for one or multiple doses Receives: Device: Laminaria; Drug: Vaginal prostaglandin |
What is being measured
The primary outcome is the main question the study is designed to answer.
o Bishop Score and cervical dilatation
Tool to assess cervical status
Measured: 2 YEARS
Secondary outcomes (2)
o Induction time to active phase of labor.
Time between start and 5cm dilatation
Measured: 2 YEARS
o Induction time to delivery time.
Time between start to delivery
Measured: 2 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Oct 2022
- Primary completion1 Mar 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor Onset and Length AbnormalitiesStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maya AbdelRazek, MD, Principal investigator, Lecturer of obstetrics and gynecology - Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151925
- Sponsor's protocol ID
- FMASU M D 63/2021
- Status last verified
- May 2021
- First submitted
- 25 May 2022
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: It will be available once approved
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laminaria Tents Versus Vaginal Prostaglandin in Cervical Ripening in Term Induction of Labor With Unfavorable Cervix:A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06151925
- Acronym / sponsor ID
- FMASU M D 63/2021
- Conditions
- Labor Onset and Length Abnormalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 30 Nov 2023 (actual)
- 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.
Mechanical methods used for induction of labor received a great attention nowadays due to the serious side effects of the pharmacological methods. Hygroscopic dilators are considered important subtype of these mechanical methods. One of them is Laminaria which is a synthetic type of sea algae that induces cervical dilation by absorbing water from the cervix and gradually increasing in thickness. The current study will compare the effectiveness and safety of laminiria and vaginal prostaglandins in induction of labor in women with unfavorable cervix.
Detailed description
A new method for induction of labor to be studied
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laminaria tents group | Active comparator | Device: Laminaria, Drug: Vaginal prostaglandinLaminaria tent used to be inserted in cervix and left for 6-12 hours |
| vaginal prostaglandin group | Placebo comparator | Device: Laminaria, Drug: Vaginal prostaglandinMisoprostol 25 mcg inserted for one or multiple doses |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Pregnant women with:
Key exclusion criteria (3 listed)
- o Presence of fetal distress.
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 |
|---|---|---|
| Laminariamechanical method for induction of labor | Device | Laminaria tents group, vaginal prostaglandin group |
| Vaginal prostaglandinAlso: VagiprostVaginal prostaglandin for ripening | Drug | Laminaria tents group, vaginal prostaglandin group |
Primary outcome
o Bishop Score and cervical dilatation
Time frame: 2 YEARS
Tool to assess cervical status
2 secondary outcomes
o Induction time to active phase of labor.
Time frame: 2 YEARS
o Induction time to delivery time.
Time frame: 2 YEARS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: Yes. It will be available once approved
Related trials for Labor Onset and Length Abnormalities
RecruitingPhase 2
Use of Cinnamomum Verum for Induction of Labor. Double Blind Randomized Clinical Trial
Labor Onset and Length Abnormalities, First Birth
Recruiting
The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL)
Labor Dystocia, Labor Complication
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.
Maya AbdelRazek, MD principal investigator
Lecturer of obstetrics and gynecology - Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laminaria and Vaginal prostaglandin in people with Labor Onset and Length Abnormalities, run by Ain Shams University 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 9 inclusion and 3 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: finished, as of the sponsor's last update on 30 Nov 2023. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
o Bishop Score and cervical dilatation (time frame: 2 YEARS). 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 30 Nov 2023.