IUDNCT06864078
IUCD Insertion in Patients Delivered by Cesarean Section
A study testing IUD Insertion during Cesarean Section and lidocaine gel and diclofenac potassium tablets in people with IUD, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Long-acting reversible contraceptive (LARC) methods, including intrauterine devices (IUDs), are highly effective and safe options for preventing unintended pregnancies. IUDs have failure rates below one percent, making them one of the most reliable forms of contraception available. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- IUD
- What is being tested?
- IUD Insertion during Cesarean Section and lidocaine gel and diclofenac potassium tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2023to 10 Aug 2024
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women at term pregnancy willing to give birth at the hospital, either via c-section or vaginal delivery.- - - Singleton pregnancy with viable fetus.
- Women who are willing and able to provide informed consent to participate in the study.
- Women who are able to communicate in the language of the study, either verbally or through a translator
Who cannot join
- Women who have a medical condition that would prevent them from participating in the study, such as severe mental illness.
- Women with medical disorder during pregnancy as pre-eclampsia.
- Having a history of dystocia or instrumental delivery, stillbirth, giving birth to a child with a weight of less than 2500 grams, having a history of general medical conditions, disabilities, depression, drug intake, major psychological problems, or having stress-inducing experiences such as the loss of a family member, divorce, or family problems.
- Individuals with medical conditions such as low back pain, chronic constipation, urination problems, or breast problems before pregnancy.
- Women who have had multiple c-sections in the past.
- Women who were not able to give a birth vaginally due to medical reasons such as placenta previa, cord prolapse, or fetal distress.
- Women who are not willing or able to provide informed consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diclofenac Potassium and Lidocaine Gel in Posterior Vaginal Fornix Prior to IUCD Insertion in Patients Delivered by Cesarean Section
Long-acting reversible contraceptive (LARC) methods, including intrauterine devices (IUDs), are highly effective and safe options for preventing unintended pregnancies. IUDs have failure rates below one percent, making them one of the most reliable forms of contraception available.
They are suitable for females of all ages, including adolescents and nulliparous women, and offer long-term protection without requiring daily adherence, unlike oral contraceptives. Increasing the utilization of IUDs can provide a safe, long-acting, highly effective, and reversible method of contraception, reducing the incidence of unintended pregnancies and associated complications.
Read the detailed description
One of the primary concerns for women who have undergone a C-section is the recovery time. C-sections are major surgeries, and the recovery process can be longer and more uncomfortable than that of a vaginal delivery. Women who have had a C-section may experience pain, discomfort, and fatigue for several weeks after the procedure. Additionally, they may be required to take pain medication, which can cause side effects such as nausea and drowsiness.
Women who have had a C-section may also experience emotional difficulties following the procedure. The recovery process can be difficult, and the physical limitations imposed by the surgery may make it difficult for women to care for their newborns. Additionally, some women may feel a sense of disappointment or failure if they were not able to deliver their baby vaginally.
On the other hand, vaginal delivery is considered to be less invasive than a C-section, and the recovery process is typically faster and less uncomfortable. Women who have had a vaginal delivery may be able to return to their normal activities more quickly than those who have had a C-section. Additionally, vaginal delivery allows for immediate skin-to-skin contact between the mother and baby, which can promote bonding and breastfeeding.
Another advantage of vaginal delivery is that it is associated with a lower risk of complications for both the mother and the baby. C-sections are considered to be major surgeries, and as such, they carry a higher risk of complications such as infection, bleeding, and blood clots. Additionally, babies born via C-section are at a slightly higher risk of respiratory problems and other complications.
One of the most important factors in determining the quality of life after childbirth is the woman's physical and emotional well-being. Women who have had a C-section may experience more physical discomfort and emotional distress in the immediate aftermath of the procedure. However, the long-term effects of C-sections on a woman's physical and emotional well-being are not well understood.
Despite their effectiveness, IUD insertion can be associated with significant discomfort and pain, which may deter some women from choosing this contraceptive method. Pain during IUD insertion arises from several factors, including myometrial contractions triggered by the device irritating the uterine cavity, passage through the cervical canal, and the application of a tenaculum to stabilize the cervix. The insertion process involves measuring the uterine cavity with a sound, followed by advancing the IUD through the cervix and into the uterus, all of which can stimulate pain receptors and cause discomfort.
Expulsion of an IUD occurs in approximately one in twenty women, with the highest risk during the first three months following insertion, particularly after menstruation. Proper training for healthcare providers and the use of pain management strategies can help minimize these risks and improve the overall experience for women undergoing IUD insertion.
Pharmacological interventions to alleviate pain during IUD insertion include local anesthetics, nonsteroidal anti-inflammatory drugs (NSAIDs), and prostaglandins to soften the cervix. However, there is considerable variability in the application of these strategies, with no universally accepted pain management protocol.
Diclofenac potassium is a potent, rapidly acting NSAID with well-documented analgesic properties.
The combined use of diclofenac potassium and lidocaine gel offers a dual approach to pain relief. Lidocaine gel alleviates pain originating from cervical instrumentation, such as tenaculum application and passage of the sound and IUD through the cervical canal, while diclofenac potassium mitigates pain from the uterus and cervix by inhibiting inflammatory pathways
- Conditions
- IUD
- Being tested
- IUD Insertion during Cesarean Section, lidocaine gel and diclofenac potassium tablets, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IUD Insertion during Cesarean SectionDevice
to evaluate the analgesic effect of diclofenac potassium and lidocaine gel applied to the posterior vaginal fornix before IUD insertion in women who had previously undergone cesarean section. By assessing the efficacy of this pain management strategy, this study seeks to contribute to the optimization of IUD insertion protocols, improving patient comfort and increasing the acceptance of this highly effective contraceptive method.
lidocaine gel and diclofenac potassium tabletsDrug
lidocaine gel and diclofenac potassium tablets
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group I (Study Group) | Active comparator | About 64 women who received lidocaine gel and diclofenac potassium tablets,to be administered 1 hour before planned intrauterine device insertion (Cu T380A) insertion, according to the assigned group. A syringe consists of six millimeters of two percent lidocaine gel (Xylocaine Jelly, AstraZeneca, Australia) for the active management group Receives: Device: IUD Insertion during Cesarean Section; Drug: lidocaine gel and diclofenac potassium tablets |
| Control Group | Placebo comparator | About 64 women who received placebo tablets and placebo gel,2 placebo tablets to be administered 1 hour before planned intrauterine devices insertion (Cu T380A) insertion,six millimeter of placebo gel (K-Y jelly, Johnson \& USA, Johnson). Receives: Device: IUD Insertion during Cesarean Section; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Management
Assessing the efficacy of the pain strategy resulted from IUD insertion By using VAS scale and improving patient comfort and increasing the acceptance of this highly effective contraceptive method
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start10 Sep 2023
- Primary completion5 Aug 2024
- Study completion10 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IUDStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safaa Bashandy Hussein, Al-Azhar University
- Investigators
- Yousry Omar Salim El Maraghy, Professor, Study chair, Obstetrics and Gynecology, Faculty of medicine Al-Azhar University Assuit.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864078
- Sponsor's protocol ID
- Safaa Bashandy
- Status last verified
- Sep 2023
- First submitted
- 4 Mar 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diclofenac Potassium and Lidocaine Gel in Posterior Vaginal Fornix Prior to IUCD Insertion in Patients Delivered by Cesarean Section
- ClinicalTrials.gov ID
- NCT06864078
- Acronym / sponsor ID
- Safaa Bashandy
- Conditions
- IUD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Sep 2023 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 10 Aug 2024 (actual)
- First posted
- 7 Mar 2025 (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.
Long-acting reversible contraceptive (LARC) methods, including intrauterine devices (IUDs), are highly effective and safe options for preventing unintended pregnancies. IUDs have failure rates below one percent, making them one of the most reliable forms of contraception available.
They are suitable for females of all ages, including adolescents and nulliparous women, and offer long-term protection without requiring daily adherence, unlike oral contraceptives. Increasing the utilization of IUDs can provide a safe, long-acting, highly effective, and reversible method of contraception, reducing the incidence of unintended pregnancies and associated complications.
Detailed description
One of the primary concerns for women who have undergone a C-section is the recovery time. C-sections are major surgeries, and the recovery process can be longer and more uncomfortable than that of a vaginal delivery. Women who have had a C-section may experience pain, discomfort, and fatigue for several weeks after the procedure. Additionally, they may be required to take pain medication, which can cause side effects such as nausea and drowsiness.
Women who have had a C-section may also experience emotional difficulties following the procedure. The recovery process can be difficult, and the physical limitations imposed by the surgery may make it difficult for women to care for their newborns. Additionally, some women may feel a sense of disappointment or failure if they were not able to deliver their baby vaginally.
On the other hand, vaginal delivery is considered to be less invasive than a C-section, and the recovery process is typically faster and less uncomfortable. Women who have had a vaginal delivery may be able to return to their normal activities more quickly than those who have had a C-section. Additionally, vaginal delivery allows for immediate skin-to-skin contact between the mother and baby, which can promote bonding and breastfeeding.
Another advantage of vaginal delivery is that it is associated with a lower risk of complications for both the mother and the baby. C-sections are considered to be major surgeries, and as such, they carry a higher risk of complications such as infection, bleeding, and blood clots. Additionally, babies born via C-section are at a slightly higher risk of respiratory problems and other complications.
One of the most important factors in determining the quality of life after childbirth is the woman's physical and emotional well-being. Women who have had a C-section may experience more physical discomfort and emotional distress in the immediate aftermath of the procedure. However, the long-term effects of C-sections on a woman's physical and emotional well-being are not well understood.
Despite their effectiveness, IUD insertion can be associated with significant discomfort and pain, which may deter some women from choosing this contraceptive method. Pain during IUD insertion arises from several factors, including myometrial contractions triggered by the device irritating the uterine cavity, passage through the cervical canal, and the application of a tenaculum to stabilize the cervix. The insertion process involves measuring the uterine cavity with a sound, followed by advancing the IUD through the cervix and into the uterus, all of which can stimulate pain receptors and cause discomfort.
Expulsion of an IUD occurs in approximately one in twenty women, with the highest risk during the first three months following insertion, particularly after menstruation. Proper training for healthcare providers and the use of pain management strategies can help minimize these risks and improve the overall experience for women undergoing IUD insertion.
Pharmacological interventions to alleviate pain during IUD insertion include local anesthetics, nonsteroidal anti-inflammatory drugs (NSAIDs), and prostaglandins to soften the cervix. However, there is considerable variability in the application of these strategies, with no universally accepted pain management protocol.
Diclofenac potassium is a potent, rapidly acting NSAID with well-documented analgesic properties.
The combined use of diclofenac potassium and lidocaine gel offers a dual approach to pain relief. Lidocaine gel alleviates pain originating from cervical instrumentation, such as tenaculum application and passage of the sound and IUD through the cervical canal, while diclofenac potassium mitigates pain from the uterus and cervix by inhibiting inflammatory pathways
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Study Group) | Active comparator | Device: IUD Insertion during Cesarean Section, Drug: lidocaine gel and diclofenac potassium tabletsAbout 64 women who received lidocaine gel and diclofenac potassium tablets,to be administered 1 hour before planned intrauterine device insertion (Cu T380A) insertion, according to the assigned group. A syringe consists of six millimeters of two percent lidocaine gel (Xylocaine Jelly, AstraZeneca, Australia) for the active management group |
| Control Group | Placebo comparator | Device: IUD Insertion during Cesarean Section, Drug: PlaceboAbout 64 women who received placebo tablets and placebo gel,2 placebo tablets to be administered 1 hour before planned intrauterine devices insertion (Cu T380A) insertion,six millimeter of placebo gel (K-Y jelly, Johnson \& USA, Johnson). |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women at term pregnancy willing to give birth at the hospital, either via c-section or vaginal delivery.- - - Singleton pregnancy with viable fetus.
- Women who are willing and able to provide informed consent to participate in the study.
- Women who are able to communicate in the language of the study, either verbally or through a translator
Key exclusion criteria (7 listed)
- Women who have a medical condition that would prevent them from participating in the study, such as severe mental illness.
- Women with medical disorder during pregnancy as pre-eclampsia.
- Having a history of dystocia or instrumental delivery, stillbirth, giving birth to a child with a weight of less than 2500 grams, having a history of general medical conditions, disabilities, depression, drug intake, major psychological problems, or having stress-inducing experiences such as the loss of a family member, divorce, or family problems.
- Individuals with medical conditions such as low back pain, chronic constipation, urination problems, or breast problems before pregnancy.
- Women who have had multiple c-sections in the past.
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 |
|---|---|---|
| IUD Insertion during Cesarean Sectionto evaluate the analgesic effect of diclofenac potassium and lidocaine gel applied to the posterior vaginal fornix before IUD insertion in women who had previously undergone cesarean section. By assessing the efficacy of this pain management strategy, this study seeks to contribute to the optimization of IUD insertion protocols, improving patient comfort and increasing the acceptance of this highly effective contraceptive method. | Device | Control Group, Group I (Study Group) |
| lidocaine gel and diclofenac potassium tabletslidocaine gel and diclofenac potassium tablets | Drug | Group I (Study Group) |
| PlaceboPlacebo | Drug | Control Group |
Primary outcome
Pain Management
Time frame: 2 hours
Assessing the efficacy of the pain strategy resulted from IUD insertion By using VAS scale and improving patient comfort and increasing the acceptance of this highly effective contraceptive method
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 7 Mar 2025.
- Individual participant dataSharing planned: Undecided
Related trials for IUD
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Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer
Atypical Endometrial Hyperplasia, Stage I Uterine Corpus Cancer AJCC v7
RecruitingObservational study
Postprandial Glucose Handing in Contraceptive and IUD Users
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Primitive Immunodeficiency, Intrauterine Devices and Menstrual Hygiene Products
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A Study to Estimate Early Clinical Efficacy Signals of GLP-1 Agonist Administration in Conjunction With Levonorgestrel Intrauterine Device in Obese Patients With Endometrioid Intraepithelial Neoplasia
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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.
Yousry Omar Salim El Maraghy, Professor study chair
Obstetrics and Gynecology, Faculty of medicine Al-Azhar University Assuit.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IUD Insertion during Cesarean Section and lidocaine gel and diclofenac potassium tablets in people with IUD, run by Al-Azhar 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 3 inclusion and 7 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 7 Mar 2025. 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?
Pain Management (time frame: 2 hours). 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 7 Mar 2025.